U.S. FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
MEDICAL DEVICES ADVISORY COMMITTEE
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GENERAL AND PLASTIC SURGERY DEVICES PANEL
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66TH MEETING
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MONDAY,
APRIL 11, 2005
The Panel met at 8:00 a.m. in Salons A, B,
and C of the Hilton Washington, D.C.
North/Gaithersburg, 620 Perry Parkway,
Gaithersburg,
Maryland, MICHAEL A. CHOTI, M.D., Chairman,
presiding.
PRESENT:
MICHAEL A. CHOTI, M.D., Chairman
GRACE T. BARTOO, Ph.D., RAC, Industry
Representative
BRENT A. BLUMENSTEIN, Ph.D., Voting Member
LEIGH F. CALLAHAN, Ph.D., Temporary Voting Member
LEELEE DOYLE, Ph.D., Consumer Representative
CHERYL A. EWING, M.D., Voting Member
A. MARILYN LEITCH, M.D., Voting Member
STEPHEN LI, Ph.D., Temporary Voting Member
JOSEPH LoCICERO III, M.D., Voting Member
BARBARA R. MANNO, Ph.D., Temporary Voting Member
MICHAEL J. MILLER, M.D., Voting Member
AMY E. NEWBURGER, M.D., Voting Member
DAVID KRAUSE, Ph.D., Executive Secretary
I‑N‑D‑E‑X
AGENDA ITEM: PAGE
Call to Order 3
Conflict of Interest and Opening Remarks 4
David Krause, Ph.D. Executive Secretary
Panel Introductions 6
Michael Choti, M.D., Chairman
Panel Update 13
CDR Stephen R. Rhoades, USPHS, Acting Deputy
Director, Division of General, Restorative,
and Neurological Devices, Office of Device
Evaluation
Welcoming Remarks 16
Miriam Provost, Ph.D., Acting Director,
DGRND, ODE
Open Public Comment 26
P‑R‑O‑C‑E‑E‑D‑I‑N‑G‑S
(8:05
a.m.)
CALL
TO ORDER
EXECUTIVE
SECRETARY KRAUSE: Good morning
everybody. If we could have everybody
find a chair? We're trying to get the
speakers. There are still some speakers
outside. And it's the staff trying to
get them in. So we may have to wait a
little bit later, but I think we'll go ahead and get started now. And then if everybody's not quite ready,
we'll just hold up a few minutes. But I
think we'll get the meeting started so that we can at least try to keep close
to schedule.
Good
morning, everyone. We're ready to begin
the 66th meeting of the General and Plastic Surgery Devices Panel. My name is David Krause. I'm the Executive Secretary of this
panel. And I'm also a biologist and a
reviewer in the Plastic and Reconstructive Surgery Devices Branch in the
Division of General, Restorative, and Neurological Devices.
I'd
like to remind everyone that you are requested to sign in on the attendants'
sheets, which are available at the tables by the doors just outside. You may also pick up an agenda, a panel
member roster, and information about today's meeting out there on the tables.
The
information includes how to find out about future meeting dates through the
advisory panel phone line and how to obtain meeting minutes or transcripts.
Before
I turn the meeting over to Dr. Choti, I'm required to read a statement into the
record regarding conflict of interest.
CONFLICT
OF INTEREST AND OPENING REMARKS
EXECUTIVE
SECRETARY KRAUSE: "The following
announcement addresses conflict of interest issues associated with this meeting
and is made a part of the record to preclude the appearance of an impropriety.
"To
determine if any conflict existed, the agency reviewed the submitted agenda for
this meeting and all financial interests reported by the committee
participants.
"Conflict
of interest statutes prohibit special government employees from participating
in matters that could affect their or their employers' financial
interests. However, the agency has
determined that participation of certain members and consultants, the need for
whose services outweigh the potential conflict of interest involved, is in the
best interest of the government.
"We
would like to note for the record that the agency took into consideration
certain matters regarding Dr. Miller.
Dr. Miller reported his institution's past and current involvement with
firms at issue.
"In
the absence of personal financial interest, the agency has determined that he
may participate fully in the panel's deliberations. In the event that the discussions involve any other products or
firms not already on the agenda for which an FDA participant has a financial
interest, a participant should excuse him or her self from such
involvement. And the exclusion will be
noted for the record.
"With
respect to all other participants, we ask in the interest of fairness that all
persons making statements or presentations disclose any current or previous
financial involvement with any firm whose products they may wish to comment
upon."
At
this point I'd like to turn the meeting over to Dr. Choti, the chairman.
CHAIRMAN
CHOTI: Thank you, Dr. Krause, and good
morning.
My
name is Dr. Michael Choti. I'm in the
Division of Surgical Oncology at Johns Hopkins University. And I am the standing chair of this panel.
During
this three‑day meeting, we, our panel, would like to make recommendations
to the Food and Drug Administration on two pre‑market approval
applications.
PANEL
INTRODUCTIONS
CHAIRMAN
CHOTI: The next item of business is to
introduce the panel members, who are giving their time to help the FDA in these
matters and the FDA staff here at the table.
I'm going to ask each person to introduce him or herself, starting with
both the area of expertise, position title, institution, and his or her status
on the panel, either voting member or industry. Let me start on the left side of the panel here with Dr. Bartoo.
MEMBER
BARTOO: My name is Grace Bartoo. I'm the General Manager of Decus
Biomedical. I have experience in
biomedical engineering. That's what my
training is in. But I also have a lot
of experience in clinical trials and medical advice research.
I
am the industry representative for the panel.
MEMBER
DOYLE: My name is LeeLee Doyle. I have a Ph.D. in reproductive
physiology. I am a Professor Emeritus
of Obstetrics and Gynecology and currently the Assistant Dean for Faculty
Development at the University of Arkansas for Medical Sciences College of Medicine.
I
am the consumer representative, a nonvoting member.
MEMBER
BLUMENSTEIN: My name is Brent
Blumenstein. I am a
biostatistician. I work independently
from Seattle, Washington.
MEMBER
EWING: My name is Cheryl Ewing. I am a faculty member at the University of
California at San Francisco in the Department of Surgery in surgical oncology
with a specialty in breast oncology.
MEMBER
NEWBURGER: I'm Dr. Amy Newburger. I'm a dermatologist in private practice,
Director of Dermatology Consultants of Westchester. I teach at St. Luke's‑Roosevelt Hospital Medical
Consortium.
MEMBER
LoCICERO: I'm Joseph LoCicero. I'm a thoracic surgeon specializing in
foregut surgery. I'm Professor and
Chair of Surgery at the University of South Alabama.
And
I am a voting member.
MEMBER
MANNO: I'm Dr. Barbara Manno. I am a toxicologist. I'm a professor with the Department of
Psychiatry at the Louisiana State University Health Sciences Center in
Shreveport, Louisiana and voting today.
MEMBER
LI: My name is Steve Li. I am the President of Medical Device Testing
and Innovations in Sarasota, Florida.
My areas of expertise are biomechanics and biomaterials.
And
I am a voting member today.
EXECUTIVE
SECRETARY KRAUSE: My name is David
Krause. I am the Executive Secretary.
MEMBER
CALLAHAN: I'm Leigh Callahan. I'm a health outcomes researcher, an
epidemiologist at the University of North Carolina in Chapel Hill. I'm in the Departments of Medicine and
Orthopedics.
And
I am a temporary voting member for this panel.
DR.
MILLER: I'm Michael Miller. I am Professor and Deputy Chairman of
Plastic Surgery at University of Texas, M. D. Anderson Cancer Center.
My
clinical work involves cancer‑related reconstructive surgery. I also have appointments in biomedical
engineering with the University of Texas Center for Biomedical Engineering and
at Rice University.
MEMBER
LEITCH: I'm Marilyn Leitch. I'm a surgical oncologist at the University
of Texas Southwestern Medical Center in Dallas. I also am involved primarily in the treatment of breast cancer
patients but do see patients with benign diseases as well. And I am a professor of surgery.
DR.
PROVOST: I'm Miriam Provost. I am Acting Director for the Division of
General, Restorative, and Neurological Devices in the Office of Device
Evaluation at FDA.
EXECUTIVE
SECRETARY KRAUSE: Let me just clarify
for the record that Drs. Leitch, Miller, LoCicero, Newburger, Ewing, and
Blumenstein are all voting members on this panel. Drs. Manno, Li, and Callahan are deputized voting members. And we will read the deputization memo
tomorrow.
CHAIRMAN
CHOTI: I would like to note for the
record that the voting members present constitute a quorum, as required by 21
CFR Part 14.
Let
me read a letter from Dr. Michael Olding, who was to be a member, a nonvoting
member, on this panel. He elected not
to be present and requested that the following letter be read, "Dear Dr.
Choti, I would like to request the following statement to be read into the
record at the time of the General and Plastic Surgery Panel meeting.
"On
December 2004, I agreed to serve on this panel with great enthusiasm for its
mission and with a full understanding of the commitment and the need for
impartiality. Accordingly, I completed
the required conflict of interest statement in January 2005, indicated that
there are no conflicts.
"Subsequently,
on March 21st, 2005, Medicus Pharmaceutical Corporation announced plans to
merge with Inamed Corporation, a firm at issue. That merger is subject to approval by stockholders, regulatory
approvals, and customary closing conditions according to the companies.
"Upon
learning of the planned merger, I immediately notified the Executive Secretary
of the proposed merger and that I owned a quantity of stock in Medicus.
"Initially,
on April 1st, 2005, the Executive Secretary indicated that my service on the
panel would not be affected by my stock holdings and the planned merger, but
one business day before this meeting, on Friday, April 8th, I received a fax
from Integrity Committee and Conference Management Branch informing me that due
to the stock‑holding value, between 50,000 and 100,000, in a firm that is
slated to merge with a firm at issue, I would be excluded from voting on the
panel. It does appear that I would be
allowed to 'review and discuss matters before the panel,' even though I am
denied the right to vote.
"As
the chronology demonstrates, the incipient conflict was created by the decision
of the two companies to merge and not by any action on my part. Indeed, I made the FDA aware of the
situation.
"I
was fully prepared and committed to continuing my service on the panel
impartially and a relatively small stock‑holding I have in the company,
which until March 2005 had no interest in the outcome of our work, would have
no bearing on my decision‑making process.
"I
do not feel it is appropriate for me to continue my service on the panel as a
partial member; that is, one without voting rights. Since the FDA has concluded that my voting may create an
appearance of a conflict due to my stock holdings, I do not want my continued
service as a nonvoting panel member to be suspect in any way.
"I
regret having to make this decision as I possess important experience as a
plastic surgeon for the panel to consider.
And my departure will leave only one other professional with similar
experience. But the handicap that the
FDA has placed upon me because of the incipient conflict, not of my making,
that arose since my appointment to the panel makes my decision necessary.
"Thank
you for your consideration and understanding.
And good luck to you and the panel in your important work. Sincerely, Michael Olding."
Now
I would like to introduce Commander Stephen Rhoades, the Acting Deputy Director
of the Division of General, Restorative, and Neurological Devices, who will
update the panel since the last meeting.
Dr.
Rhoades?
CDR
RHOADES: Thank you, Dr. Choti.
PANEL
UPDATE
CDR
RHOADES: I am Stephen Rhoades. I am the Acting Deputy Director in the Division
of General, Restorative, and Neurological Devices. Welcome, members of the panel, members of the public, and
manufacturers, to this important three‑day meeting of the General and
Plastic Surgery Devices Panel on two silicone gel‑filled breast implants.
Tomorrow
you will make recommendations and vote on Inamed Corporation's pre‑market
approval application. On Wednesday, you
will make recommendations and vote on Mentor Corporation's pre‑market
approval application.
Because
of the high public interest in silicone gel‑filled breast implants, in
addition to the regular public comment periods for any PMA discussion, we have
scheduled a full day for a public comment on issues related to silicone gel‑filled
breast implants.
This
panel last met on March 25th of 2004, at which time you recommended approval of
Dermik Laboratories pre‑market approval application for their Sculptra
dermal filler for lipoatrophy in HIV‑positive patients. This device application was approved on
August 3rd with a conditional post‑approval study to evaluate long‑term
safety.
On
April 22nd of 2004, FDA approved Genzyme Corporation's Hylaform dermal filler
for moderate to severe facial wrinkles and folds.
This
panel recommended approval of this device at the November 21st, 2003 panel
meeting. The approval included a
condition for a post‑approval study in patients with Fitzpatrick IV to VI
skin types.
On
August 9th, 2004, FDA issued a final rule classifying silicone sheeting for the
management of closed hyperproliferative scars as Class I devices exempt from
pre‑market notification. This
panel recommended that these be Class I‑exempt at the July 24th, 2003
panel meeting.
The
agency appreciates the commitment of the panel members. And we also appreciate the comments of the
representatives of the 30 professional organizations and 145 members of the
public who have requested time to address the panel today.
Thank
you for your attention. I would now
like to introduce Dr. Miriam Provost for a few words.
WELCOMING
REMARKS
DR.
PROVOST: Good morning. As Commander Rhoades said, I am Miriam
Provost. I am the Acting Director for
the Division of General, Restorative, and Neurological Devices.
I
would like to just take a few minutes and give everyone a brief regulatory
background followed by a discussion of why we have convened this meeting and
what are we asking you, our distinguished advisory panel, to do.
First,
some background on the regulatory status of silicone gel‑filled breast
implants. Prior to 1991, silicone gel‑filled
breast implants were sold on the market either as pre‑amendments devices,
which means they were on the market prior to May 1976, or as a 510(k)‑cleared
device.
In
April 1991, FDA issued a regulation that required all manufacturers of silicone
gel‑filled breast implants to submit safety and effectiveness data in
PMAs in order for their products to remain on the market.
Several
PMAs were submitted and presented to an advisory panel in November 1991 and
then again in February 1992. In April
1992, FDA determined that the PMAs did not include adequate safety data to
support approval. However, at the same
time, FDA believed there was a public health need to have breast implants
available for reconstruction in revision patients.
In
1992, because FDA believed it was important to provide continued availability
of silicone gel‑filled breast implants for women seeking breast
reconstruction or revision, we developed a new type of study design referred to
by industry and the FDA as an adjunct study.
Inamed
in 1998 and Mentor in 1992 are the only two companies that have received FDA
approval for an adjunct study. Inamed's
and Mentor's adjunct studies currently remain active. Both adjunct studies require five‑year follow‑up for
each patient enrolled. And there is no
limit on the enrollment of reconstruction or revision patients or on the number
of investigational sties.
Adjunct
studies are focused on the collection of safety data and do not include MRIs
screening for silent rupture. The 1992
agreements between FDA and industry also described information to be collected
in the study design to evaluate safety and effectiveness to support a PMA, the
so‑called "core study."
The
investigational device exemption, or IDE, studies are the mechanism by which
the core study data, which you will hear referenced during this panel meeting,
are collected.
Inamed
submitted and received approval for their core study in 1998. Mentor submitted and received approval for
their core study in 2000.
At
the current time, FDA has not approved any PMAs for silicone gel‑filled
breast implants. They remain
investigational devices, which means that a patient must be enrolled in an
adjunct study or an IDE study in order to receive one of these implants in the
U.S.
I'd
also like to note that in January 2004, FDA issued a draft update of our
guidance document for manufacturers of breast implants. This document is a framework for breast
implant manufacturers. And it includes
recommendations on the kind of information that FDA recommends be provided in a
PMA.
We
have received numerous comments on the draft guidance. And at the present time, we are continuing
to review the comments that we received.
Once we have reviewed the comments and made revisions, as appropriate,
the guidance document will be released in final.
It
should be emphasized that our review of the information in a PMA is not
affected by whether a guidance document for the product in question is in draft
or final form. As is the case for all
medical device applications, FDA will base our decisions on the scientific and
clinical data in the PMAs as well as the panel's deliberations and
recommendations regarding those data.
Now
for the task at hand. Inamed's PMA,
P020056, was presented previously at the October 2003 meeting of the General
and Plastic Surgery Devices Advisory Panel.
The panel recommended in a nine to six vote that the PMA was approvable
with conditions.
In
January of 2004, after considering the data in the PMA and the panel's
deliberations of the data, we determined that the PMA was not approvable
because the data did not provide a reasonable assurance of safety for the
device.
Therefore,
FDA's presentation at this panel meeting for the Inamed PMA will focus on the
additional information submitted by Inamed to address the outstanding safety
issues. The Inamed PMA will be the
panel's focus on Tuesday.
Mentor's
PMA, P030053, is being presented for the first time at a panel meeting. Therefore, FDA's presentation for this PMA
will involve a summary of all relevant preclinical and clinical data. The Mentor PMA will be the panel's focus on
Wednesday.
It
should be noted that, although the core study is the primary source of clinical
data for both PMAs, both sponsors use data and information from multiple
sources to address the key safety issues.
Based
on your own scientific and clinical knowledge, we are asking you, the panel, to
discuss the data in each individual PMA and advise us as to whether there is
sufficient information to provide a reasonable assurance of safety and
effectiveness for each device.
After
the panel meeting, FDA will continue to review the information contained in
this PMA. We will carefully consider
the deliberations and recommendations that you make during this meeting. Ultimately FDA will make a decision on the
approvability of these two PMAs.
We
will also hear a number of comments from the public today as well as on Tuesday
and Wednesday. And I want to thank the
members of the public for making the effort to come here today to present their
views on these applications.
I
want to assure everyone that the FDA will carefully listen to these
comments. And, as previously stated, we
will make our decision based on the scientific data in the PMAs and the panel's
deliberations on the data.
I
do want to remind everyone, however, that this meeting is not intended as a
general referendum on silicone gel‑filled breast implants. This panel meeting focuses specifically on
the safety and effectiveness of two individual breast implant PMAs. And the object of this meeting is to obtain
input from you, the panel, on the data in these applications. The FDA is very appreciative of your giving
of your time and expertise to accomplish this important task.
Thank
you very much. And now I'm going to
turn it back over to you, Dr. Choti.
CHAIRMAN
CHOTI: Thank you, Dr. Provost.
We
will now proceed with the open public hearing session of this meeting. All persons addressing the panel are asked
to speak clearly into the microphone as the transcriptionist is depending on
this as a means to accurate recording of the meeting.
I
would like to have the attention of all of the individuals who are registered
to speak to the panel today. You have
been given a number of correspondence regarding the order of your appearance.
Please
come to the podium area in advance so that we are not spending a great deal of
time in transitions from speaker to speaker.
And we have two podiums set up in order to alternate and for time sake. The FDA panel will direct you to the
appropriate podium.
Please
remain within your time constraints as a timer will be present to help you with
this. We have many public speakers
today. And so it is extremely important
that we stay on time.
There
is a yellow light that will flash 30 seconds before your time is up. And the red light flashes as soon as your
time is up. If you're still speaking at
that time, then I will promptly instruct you to summarize and cut off. If after ten seconds that is not done, then
I have been told that the microphone will be cut off. So please try to stay to your allotted times.
Also,
regarding your written comments, please only bring to the panel your written
comments that have been submitted or your presentation slides. No additional material, please.
We
would also like to address the issue of financial disclosure. Before the Food and Drug Administration and
the public believe in transparent process for the information gathering and
decision‑making, to ensure such transparency at the open public hearing
session of the Advisory Committee meeting, the FDA believes it is important to
understand the context of an individual's presentation.
For
this reason, the FDA encourages you, the open public hearing speaker, at the
beginning of your written or oral statement to advise the Committee of any
financial relationship you may have with the sponsor; its product; and, if
known, its direct competitors. For
example, this financial information may include the sponsor's payment for your
travel, lodging, or other expenses in connection with your attendance at the
meeting. Likewise, the FDA encourages
that you at the beginning of your statement advise the Committee if you do not
have such financial relationships.
If
you do not choose to address this issue of financial relationships at the
beginning of your presentation, it will not preclude you from speaking.
Let's
begin with the first speaker. These
individuals are the ones who have notified the FDA of their intent to testify
during the open public session.
The
first speaker, please? Thank you. Good morning.
MS.
JOHNSTON: Thank you.
OPEN
PUBLIC COMMENT
MS.
JOHNSTON: Good morning. My name is Kathy Keithley Johnston. I'm the Executive Director and founder of
Toxic Discovery, a national not‑for‑profit consumer advocacy
organization. I am also a registered
nurse. And I myself used to have
silicone gel breast implants. I have no
conflicts of interest.
I
am here today carrying the voices of thousands who have been directly affected
by the failure of the FDA to require long‑term safety studies concerning
breast implants.
We
believe the FDA made the right decision in 2004 when they decided not to
approve Inamed's silicone breast implants.
The new guidance that the FDA issued at the same time was an important
step forward, demonstrating the FDA's commitment to assure that breast implants
are safe for long‑term health studies before they allow them to be widely
sold.
I
am here today counting on you to help the FDA to adhere to the guidance
document. Silicone breast implants
should not be approved until a company can prove the safety of devices for long‑term
use. Since safety cannot be proven, we
ask you to deny the manufacturer's application.
Implant
lobbyists claim that there are over 100 studies of women with implants that
show no evidence of harm. That is
clearly and absolutely false. These
groups conveniently ignore the following studies: a study by the FDA of women with silicone breast implants that at
least found for six years that women had at least one failed breast implant,
even though they did not know it. This
is referred to as a "silent rupture."
That
same study found that 21 percent had silicone leakage outside the scar capsule
surrounding their implant. From there,
silicone could harm breast tissue, could migrate into lymph nodes and, thereby,
travel to lungs, liver, or other vital organs.
The
FDA also found that women with leaking silicone breast implants were more
likely to report fibromyalgia and other connective tissue diseases. Scientists at the National Cancer Institute
found that women having breast implants for at least seven years were twice as
likely to die of brain cancer, three times as likely to die of lung cancer, and
four times as likely to commit suicide compared to other plastic surgery
patients.
A
Canadian study found that women with breast implants for augmentation were more
likely to be hospitalized and had more physician visits than women of the same
age living in the same communities.
These
are just a few of the studies that were a serious concern about risk of
silicone leakage. Research has not yet
been done to determine exactly what chemicals leak into a woman's body and what
long‑term health consequences then results from that leakage and
migration of silicone. How can informed
consent be obtained when information is not even known by the very physician
implanting these risky devices?
Neither
Inamed nor Mentor has conducted studies of the health impact of leaking silicone
in a woman's body. Dow‑Corning
has funded one such study. In a Danish
study, Holmich claimed that leakage was not significantly related to connective
tissue disease. However, there were
only 23 women in this study with extracapsular leakage, a sample that is much
too small to provide meaningful safety data.
In fact, the study showed that women were four times as likely in that
study to report a connective tissue disease compared to women whose implants
were not ruptured. But these impressive
differences were not statistically significant because the sample was too
small.
You
would certainly think after 40 years that implant manufacturers should find
more than 23 women with extracapsular rupture.
Without a doubt, there are more than 40 in this very room today. There are hundreds of thousands of women in
this nation whose body would show you that leakage is present if testing was
provided.
Our
organization has serious concerns about the integrity of the studies conducted
by Inamed and Mentor. Patients in these
studies have informed us of their fears that they believed that their problems
with implants were never reported by their physician or the manufacturer.
In
closing, let me remind you of the duties of the FDA. First and foremost, the FDA is a public health agency charged
with protecting American consumers. The
FDA should be the consumer watchdog and not the advocate of the breast implant
manufacturer.
It
is your job to make sure that the FDA protects patient safety concerning breast
implants. This can only be done by
requiring long‑term health studies before approval and not after
approval.
It
is certainly not your job to protect the livelihood of plastic surgeons or
implant makers. Both have failed in
their promises to protect women, which will not make the situation better. It will only allow it to continue. And we ask you, please protect the women of
this nation.
CHAIRMAN
CHOTI: Thank you.
Next
speaker?
MS.
GROSS: Good morning, panel. I am Marcy Gross. I am a consultant who specializes in women's health issues. I am a member of the State of Maryland
Women's Health Promotion Council and serve on the boards of various private
health organizations.
Prior
to becoming a consultant, I worked for the Department of Health, U.S.
Department of Health and Human Services, where I was a Senior Policy Analyst
for a number of years in the Office of the Assistant Secretary for Health. And in my last position, I was the Senior
Adviser for Women's Health at the Agency for Healthcare Research and Quality,
where I served while there on the secretarial ad hoc task force on silicone
breast implants.
I
give you this resume to establish my familiarity with the issues at hand. However, I am speaking as a private
citizen. I have no financial links to
any of the applicants.
A
legacy from my six‑year tenure at AHRQ is an appreciation of the need for
a strong evidence base to support medical decisions. One of my concerns today is that an adequate evidence base for
the approval of silicone gel breast prosthesis still does not exist. Worse, a truly long‑term gold standard
study that will produce independent, objective research findings seems not to
be on the horizon.
We
do have 40 years of experience with breast implants, including 25 years when
the silicone implants were available to women, all women. They were pulled from the market for good
reason. They were associated with major
medical problems.
The
basic facts on this issue have not changed in the 14 years subsequent. First, available studies on the health
aspects of silicone gel implants are still short‑term and are often
produced by companies that manufacture the devices or materials.
Second,
the work that is available, some from FDA itself, indicates that the rate of
complications of implantation, reinfections, reoperations, and other adverse
events are sufficiently high to remain a major concern, despite advances in
materials.
Third
‑‑ and this is a change from the past ‑‑ the Mentor
applicant agrees that the devices will not last indefinitely and warned women
that they should expect to have them replaced.
So the issue becomes one of sequencing in looking at the data. Do we get the data first and approval after
or the reverse?
Letting
women be living testers I find highly objectionable since these are elective
procedures and there are alternatives, especially since the data on
improvements in the quality of life for patients undergoing implantation are
weak by accepted research standards and most especially since it is expected
the devices will fail and will have to be removed.
On
this last point, the overall failure rate, it should be noted that Mentor
acknowledges that their devices will have a finite in vivo life, which means,
really, that all will fail and need to be surgically removed. We just don't know when.
I
would assert that if this were an NIH‑funded research study, it's
unlikely it would go forward.
CHAIRMAN
CHOTI: Please sum up for us.
MS.
GROSS: Yes, please. I just ask that you have the data in hand before
you reintroduce the silicone breast implants.
Thank you for your time.
CHAIRMAN
CHOTI: Thank you.
Let
me remind the audience that speakers have three minutes unless it's a national
organization. And then it's five
minutes.
Yes,
next speaker?
MR.
SCHULTZ: Good morning. My name is William Schultz. I am representing a group of women's
organizations led by Command Trust. I
appreciate being given five minutes.
Thank you.
Thank
you for the opportunity to address this Committee on the very important
question of whether FDA should approve the applications for silicone gel breast
implants. For the record, I have no
financial ties to either of the applicants.
Congress
enacted the medical device amendments in 1976 in the wake of several tragedies,
including the Dalkon shield IUD, which killed 16 women and injured countless
others. Congress sought to remedy the
defect by a new law, the defect being that medical devices were being marketed
without any demonstration of their safety or any adequate testing.
Congress
was particularly concerned about the safety of implantable devices. The basic showing that it required
manufacturers of these devices to make was that there was a reasonable
assurance that the device was safe and effective. In the case of breast implants, efficacy is obviously not the
issue. Instead, the issue is safety.
If
you think about it, for a therapeutic product, such as a heart valve, the
safety standard entails a weighing of risk versus benefits to health. And so FDA may approve a product with
substantial risks if it finds the benefits are even greater.
But
for a cosmetic product, which is what we have before us today, there are no
therapeutic benefits. For these
products, the law does not allow approval if the product is associated with
significant risk or even if there is significant uncertainty about safety. And I think that is a very important
principle to keep in mind as we go through the next three days.
It
is also relevant that the manufacturer has the burden of proof. Where there are doubts or uncertainties,
then the product may not be approved because the manufacturer has not carried
its burden. The law does not
contemplate that the patients or consumers should bear the risk of unanswered
questions.
At
the October 2003 Advisory Committee meeting, there was discussion of various
approval conditions and post‑market studies. First, the Committee should understand that any approval
conditions are not enforceable by FDA.
Once the agency approves a product, then physicians are allowed to
deviate from restrictions on the use of the product. And FDA has no authority to enforce those restrictions.
Second,
while post‑market studies may be useful, they cannot substitute for the
basic safety standard in the statute.
The statute does not provide that the agency may approve a product now
and allow the demonstration of safety at a later date.
At
the last Advisor Committee meeting, there was also discussion about whether
women should have the option or the choice of using breast implants as long as
they were fully informed.
Although
Congress has adopted the buyer beware approach for dietary supplements and in
other areas, this was not the approach that it adopted for medical
devices. Instead, for these products,
it has declared in law that medical devices are not to be available until the
manufacturer has demonstrated safety.
It is this Committee's charge to do its best to apply that law.
Congress'
approach has two important benefits.
First, it means that patients and consumers can be confident of the
safety of device products that they use.
It also creates an important incentive to the manufacturers to design
their products to meet the high standard that Congress established.
Significant
questions have been raised about the safety of breast implants. I'm not going to address those. But it's important, of course. These products are going to be in the body
for many years. Even though the
manufacturers have known about the standards of the statute for more than 25
years, we don't really have long‑term data. And given the extremely high breakage rate of these products,
lack of long‑term data raises serious problems.
In
January 2004, FDA determined that the evidence was not adequate. And the question that this Committee must
look at is whether the companies have produced additional data that is
sufficient to justify approval.
In
conclusion, approval of silicone gel breast implants without an adequate
demonstration of safety would have two very unfortunate consequences. First, we would have lost the opportunity to
require that these products be adequately tested.
And,
perhaps even more important, such a decision would send a message to other
product manufacturers that the door has been open for approval of medical
devices that do not meet the safety requirements established by law and that
patients will suffer.
Thank
you very much. And good luck.
CHAIRMAN
CHOTI: Thank you.
Next
speaker?
DR.
HELMAN: Hi. Good morning. I'm Susan
Helman from Florida. I have paid my own
way here because I feel that this panel needs to hear from women like me.
I
had breast implants for 15 years and suffered greatly. My implants ruptured. And after numerous surgeries to remove
silicone from my body, the last surgeon stated, "There is no way to remove
it all, Susan. It's migrated to all
your tissues, your organs. It's
everywhere." Silicone as well as
platinum was found in my cheek cells, bone marrow, and lymph nodes, also in my
urine and in my blood.
My
urine platinum levels when measured eight years after explantation were 25
parts per billion, which is within the range of patients receiving chemotherapy
agent cisplatin. The urine platinum
level in the general population is .04 parts per billion. So mine was more than 500 times greater.
The
platinum ion in my urine and in my tissues I found was the exact match to my
implants that they studied as well. My
body is full of ionized platinum with no known way to remove it.
As
you know, the CDC has identified platinum as a suspected toxin. Because of my ruptured implants and the
resulting exposure to silicone and platinum, I have been diagnosed with MS and
lupus and fibromyalgia and scleroderma among many other things.
And
I'm sick. And I can't get health
insurance. When I need it the most, I
can't get it. I don't want anybody else
to suffer this way. I get severe
disabling headaches and nausea when I am exposed to exhaust fumes or unusual
odors of any kind, and I never had this problem before ever.
I'm
also concerned about young women of childbearing age and their children. I've heard that platinum can be transmitted
in milk. And I have platinum in my
urine. So, you know, I see no reason
why it couldn't be in breast milk.
Any
mother would be heartbroken to find out that during a cosmetic surgery,
unbeknownst to her, it caused her breast milk to be adulterated and cause
injury to her newborn child.
I
just ask that before implants are considered safe, platinum testing be done on
a random sample of women with silicone gel breast implants and on women with
implants, the breast milk of women with implants.
And,
in closing, please, please, please vote against the gel‑filled breast
implants until you're sure that the benefits far outweigh the risks. The first oath a doctor learns is do no
harm.
Thank
you.
CHAIRMAN
CHOTI: Thank you.
Next
speaker?
DR.
GLICKSMAN: Mr. Chairman and members of
the panel, my name is Dr. Caroline Glicksman.
And I am reading the testimony from my patient Valerie Hartwell, a 45‑year‑old
mother of 3 who is unable to attend today because of work requirements.
"I
would like to advise the Committee that I have no financial relationships with
anyone connected at this meeting. I had
silicone breast implants for two years.
I had them put in because of a chest wall deformity I was born with that
caused a considerable and noticeable depression along the sternum on my right
side.
"The
size of one of my breasts was considerably smaller than the other, causing me
to be extremely self‑conscious my whole life. I would not wear bathing suits or shirts with a neckline lower
than my collarbone because my deformity was so obvious.
"I
am so thrilled that I had the silicone implant option available to me. It has made a dramatic difference in my self‑esteem. My self‑confidence has improved
drastically.
"I
have one anatomical implant on the defective side, which has helped with the
depression along my sternum. The other
implant is round, to create uniformity.
I have had absolutely no side effects.
"My
breasts remain soft and natural‑looking, which is very important to
me. They feel natural as well. I am able to sleep comfortably in any
position. I have had no problem with
hardness and no dimpling.
"My
husband and I were concerned that I would lose nipple sensitivity. That has not been the case at all. I am so pleased with the results. I am a grateful recipient of a wonderful
product that has made a huge difference in my life.
"Thank
you, Valerie Hartwell."
CHAIRMAN
CHOTI: Thank you.
Next
speaker, please? Good morning.
MR.
BRENT: Good morning. My name is Ed Brent. And I am representing my wife, P. J. Brent,
and our children.
My
wife had silicone breast implants for ten years. She had no problems at first but became increasingly ill. On May 29th, 2000, my wife committed
suicide. She left behind seven
children. On behalf of my wife and my
seven children, I urge this panel and the FDA not to approve silicone breast
implants unless there is clear evidence that the implants being sold now are
safe for long‑term use, meaning ten years or more.
Several
studies have shown higher rates of suicide among breast implant patients. And a National Cancer Institute study found
that women with implants were four times as likely to kill themselves as other
plastic surgery patients.
The
implant makers think the explanation is that women with breast implants had
lower self‑esteem before they got their implants, but there is no reason
to think that women who decide to get implants have lower self‑esteem
than women who decide to get liposuction, nose jobs, or any other plastic
surgery.
My
wife was not a woman with low self‑esteem. She was a vibrant, loving wife and mother. P. J. loved the way she looked the first few
years after her implants. Then she began
to get sick, and her joints hurt, her fingers would swell. She had lupus‑like symptoms and was
diagnosed with fibromyalgia.
P.
J. breast‑fed two of our daughters after getting implants. Both are seriously ill. My daughter Catherine, who is with me now,
was diagnosed with chronic inflammatory demyelinating polyneuropathy as well as
esophageal motility disorder. She spent
years in leg braces, and now the leg braces have been replaced with a
wheelchair.
Our
daughter Christine also has esophageal motility disorder and leg weakness as
well. In contrast, our five children
born before my wife got breast implants are perfectly healthy.
After
P. J. committed suicide, an autopsy was performed. Large amounts of platinum were found in her body. And a doctor at the CDC after seeing the
amount of platinum in P. J.'s body said she could not have been in her right
mind.
Tissue
samples from our daughters who had breast‑fed found that they, too, had
elevated platinum levels. These
findings were presented at a meeting of the American Chemical Society last
year.
P.
J. felt terrible guilt that her two daughters had been so seriously harmed by
her decision to get breast implants. It
was not her fault. She had no way of
knowing what would happen. Most doctors
did not know that there had not been any long‑term studies on the breast
implants.
Just
two months before my wife's death, she testified at a previously FDA meeting on
breast implants. She felt the panel
ignored testimony given by women with implants.
And
I am here today to ask you to listen to these patients and their loved ones and
do not endorse a product not proven safe for long‑term use. Women and their yet unborn children may be
forever affected. This is a scientific
issue and a moral issue.
Thank
you.
CHAIRMAN
CHOTI: Thank you.
Next? Good morning.
MS.
HICKEY: Good morning. I am Lisa Hickey, and I am from
Phoenix. I have no conflicts of
interest.
I
am here to tell you I experienced four surgeries in four years due to
complications with implants. My
experience involved three manufacturers and new and improved products. Two of the surgeries were back to back after
a rupture occurred.
Concurrent
with the implant exposures, I experienced serious systemic illness and visual
and motor impairment, which improved considerably after the implants and
capsules were removed.
After
the rupture diagnosis, I was required to sign a Mentor informed consent
document in order to receive replacements.
That occurred after a moratorium had been placed on the implants that I
knew nothing about.
During
prep for the rupture removal, I was sedated and negotiated with for my rupture
evidence. My baseline mammogram and
evidence were taken away from me around the same time as that surgery.
If
implants are so safe, why are there gag orders and sealed documents regarding
silicone implants from an historical perspective? Now I understand that the Justice Department has entered a
settlement agreement with manufacturers for recovery of enormous expenses paid
out to Health and Human Services claims for breast implant complications.
Aren't
Social Security and Medicare in enough trouble already? How is it that the Justice Department can
recover its losses with the Daubert rule in place, not allowing important
evidence from expensive medical testing, while at the same time there is a law
in place requiring insurance to cover breast cancer reconstruction with
implants?
And
I have been told the Navy Department is conducting a large breast cancer
study. I am a furloughed flight
attendant for a struggling airline that is required to pay for products with
high complication rates for reconstructions when the Justice Department is
trying to recover U.S. losses incurred by enormous claims from complication.
Now,
I do not have a fancy degree or knowledge about rocket science, but my
grandparents were educators. And they
taught me to read the road signs on the highway of life. I can read that things just don't add up to
safety when it comes to silicone gel.
Many
of my fellow flight attendant friends and acquaintances with implant exposures
have been ill. And some have passed on
in the prime of their lives.
Is
silicone research taking place in the morgue?
In your approval process, please consider what this research does not
tell you. Breast implant exposures
altered my health forever. Believe me,
experiencing illness serious enough to have my implants cut out in hopes of
feeling better did not improve my self‑esteem.
I
implore you to help ensure that what happened to me and my friends with
silicone exposures never happens to anyone else, especially young women in
childbearing years, single mothers with limited financial resources, and
vulnerable cancer patients.
Thank
you.
CHAIRMAN
CHOTI: Thank you.
Next? Good morning.
MS.
P. DOWD: Good morning. Mr. Chairman, ladies and gentlemen of the
panel, I thank you for this opportunity to come before my government and speak
on the dangers of silicone gel breast implants. I come as a little David to approach the giants of the silicone
industry.
My
name is Pam Dowd of Boise, Idaho. I
represent Implant Veterans of Toxic Exposure.
I have driven almost 2,500 miles in a 1984 Southwind motor home at my
own expense to be here. I felt it was
that critical.
On
May 21st, I will reach my 30th year of being free of breast cancer. In 2003, I told the panel about my
experience as a breast cancer survivor and about the failed reconstruction that
included three ruptured silicone breast implants. I told the panel about the excruciating pain of a spontaneous
rupture that literally had me pulling at my hair, about the experience of
having my chest scraped and cauterized following the explant, and that the
Mentor implants of 1988 that caused me to cough constantly and choke on my own
saliva for seven years, and about the pain in the long bones that at times has
me screaming in pain.
Today
I come to address the issue of the denial of health care insurance for women
who have had breast implants. On page 5
of the Mentor Corporation 48‑page informed consent is this warning. Inamed does not provide this information
online. "For patients who have
undergone breast implantation, either as a cosmetic or a reconstructive
procedure, health insurance premiums may increase, coverage may be dropped,
and/or future coverage may be denied.
Treatment of complications may not be covered as well. You should check with your insurance company
regarding these coverage issues."
Ladies
and gentlemen, there is no "may" about this critical health crisis
with implanted women. The denial of
health insurance to women who have had implants is increasing across the land. Until last year, I had no personal knowledge
of being denied health insurance.
Last
October, my late husband went on Medicare.
And we lost his COBRA insurance.
For 30 years, I had been covered under group policies. Blue Cross had paid for this devastation
that's called breast reconstruction.
Yet, in the end, I am denied health insurance based on the diagnosis of
Sjogren's, Raynaud's, peripheral neuropathy, fibromyalgia, and a long list of
other diagnoses I have received since getting breast implants.
Insurance
companies such as Blue Cross/Blue Shield, Equitable Life Insurance, Aetna, AARP
supplemental insurance, Prudential, Republic Bankers Life Insurance, Times
Insurance Company are denying health care coverage to women who have had breast
implants.
I
found evidence on the evidentiary CDs from the MDL that this concern was first
reported by doctors in 1989. Insurance
application forms are now asking for implant history.
If,
as the manufacturers and members of the ASPRS repeatedly claim, there is no
connection between implants and health problems, then why the insurance
denials? If there are no health risks,
then why does Blue Cross/Blue Shield of Texas have declined if implants are
explanted as their underwriting guidelines as far back as 1996? What is the toxic secret the insurance
companies know but aren't sharing?
In
1998, I presented the results of a survey of implanted women to the Institute
of Medicine. Of the respondents, 30
percent of the women were on disability and are drawing assistance for living
needs from government and charity offices.
Many of those who were disabled were disabled before the age of 50 and
within 15 years of getting breast implants.
With
Inamed's latest figures of 325,000 newly augmented women per year, this has the
probability of creating another 100,000 women on disability a year within the
next 15 years. This has the potential
of being in excess of $100 million burden on the American taxpayer.
On
pages 40 and 41 of Mentor's 48‑page informed consent are Mentor's support
of the diabolical and barbaric flat surgeries that are disabling, creating
permanent and sometimes total disability for the recipients.
The
insurance companies are already saying they are not going to pay for the health
care needs of even the reconstruction patients they have already covered.
Ladies
and gentlemen, it will be seven and a half years ‑‑
CHAIRMAN
CHOTI: Would you please sum up?
MS.
P. DOWD: ‑‑ before I am
eligible for Medicare. I am 57,
uninsured, and uninsurable.
CHAIRMAN
CHOTI: If you could please sum up for
us?
MS.
P. DOWD: Yes.
CHAIRMAN
CHOTI: Your time is up.
MS.
P. DOWD: Putting the burden of health
care of thousands of women on my child's shoulder is a task I could not in good
conscience do. Can you?
Again,
thank you for this opportunity.
CHAIRMAN
CHOTI: Thank you.
Next? Good morning.
MS.
B. DOWD: Good morning. Mr. Chairman and members of the panel, I
appreciate the opportunity to speak to you about the dangers of silicone breast
implants.
My
name is Brenna Dowd. I am from Boise,
Idaho. I came with my mother in our old
motor home. We used my father's life
insurance money to get here.
Ever
since I have been old enough to pay attention to my mother's health, she has
been sick. My dad died in
December. And now we are alone, and I
have to take care of her.
I
have never known a healthy mother. Mom
will never tell people about all the times she has been unable to walk right,
sometimes crawling, many times falling.
She would never tell you about the times when she gets confused or when
her legs hurt her so much she has to sit in a hot bath maybe three times a day
or more just to ease the pain because of the silicone breast implants.
Mom
will never tell you how she fell out of the motor home on the way here and I
was afraid she wouldn't be able to finish the trip or when we got to Hagerstown
Saturday night, she was too exhausted to even eat.
My
mother liked to go camping in the mountains in Idaho with my father. She hasn't been able to do that for a long
time. She gets too tired to do anything
physical.
Mom
has never been able to do many things other moms should be able to do with
their children, such as shop all day in the mall or play real hard with
me. Even simple walks exhaust her. She tries, but she is too sick.
In
closing, I leave a message from my father.
One of his greatest regrets in life was that he had not protected my mom
from the implants and that she could not get health insurance. He blamed himself, but Dad was not to
blame. These companies that sell
implants to innocent women and make them sick are the ones who should be held
accountable. They poisoned my mother
and robbed me of a healthy mom and my father of a healthy wife.
I
beg you to please ban silicone breast implants. Thank you.
CHAIRMAN
CHOTI: Thank you.
Next?
DR.
BERMAN: Good morning. I'm Dr. Alan Berman, Executive Director of
the American Association of Suicidology located here in Washington, D.C. For 37 years, the AAS has had as its primary
mission that of understanding suicide as a means of promoting human welfare.
I
come here today at my own expense with no financial ties to either sponsor or
any of their competitors. The majority
of Americans report having thought about suicide at some time in their lives. Most everyone decides to live because they
come to realize that their pain is temporary but death is not.
On
the other hand, some people in the midst of a crisis perceive their problems as
inescapable and feel utterly hopeless.
Tragically, some 31,000 Americans take their lives annually.
The
AAS believes it is essential to have sound empirical study of suicide. I am here to briefly discuss five studies
that have shown an increased risk of suicide among women who have undergone
breast augmentation.
Scientists
from the NCI reported that breast augmentation patients were four times as
likely to kill themselves as were other female plastic surgery patients matched
for age, socioeconomic status, health status, and habits. It is important to note that all the women
in this study had implants for at least seven years, much longer than in other
implant studies. A weakness of the
study was the confounding variables, such as depression or marital discord,
were not controlled.
Three
European studies, one each from Sweden, Finland, and Denmark, consistently
found that women who had had breast implants for augmentation were three times
more likely to complete suicide than women in the general population of those
countries.
In
the U.S., a recent study of mastectomy reconstruction patients also found a
higher rate of suicide among implant patients compared with women who underwent
mastectomies without reconstruction.
The
American Society of Aesthetic Plastic Surgeons and Dow‑Corning funded
articles concluding that the increased risk of suicide likely existed before
surgery. They argue that women who get
breast implants may be more likely to suffer from low self‑esteem and/or
depression. In addition, based on their
demographics, they may be at higher risk for suicide.
But
the research data does not back this up.
One study noted that eight percent of Danish augmentation patients had a
psychiatric admission before surgery compared to six percent of women who had
other cosmetic procedures. Danish
women, however, had to get psychiatric referrals before they could get free
augmentation from the public health system.
Clearly, this could be the reason behind this insignificant difference.
Implant
patients, like most plastic surgery patients, tend to be unhappy with the
specific body part they want changed.
But they are not less satisfied with the overall appearance or with
themselves.
A
Danish study found that women who had breast implants for augmentation were
five to seven times more likely to be taking antidepressants than women who had
breast reduction surgery or women in the general population. Women who had their implants removed and
replaced at least one time were also more likely to be taking antidepressants
than women who still had their original implants.
The
relationship between multiple implant surgeries and the use of antidepressants
may be, in part, because complications from implants contribute to depression,
but it is not possible to know if these women had a prior history of
depression.
Women
with breast implants who testified before the FDA in October 2003 provide
anecdotal evidence for the connection between pain following augmentation
surgery and suicidal thoughts. Several
women described feeling depressed and suicidal as a result of debilitating
pain, fatigue, and mental confusion, years after getting silicone breast
implants. They said when the implants
were removed, their health improved.
And they experienced less depression and less suicidal thinking.
Anecdotal
case reports such as these are for qualitative data that informs hypothesis
testing that simply has not occurred to date.
We have here an ad hoc challenge/dechallenge test that has never been
studied or rechallenged empirically.
It
is possible that women who undergo augmentation have lower self‑esteem
than other women, but studies have not supported this. Again, studies show that women who plan to
undergo augmentation tend to feel less attractive regarding their breasts but
do not have overall lower self‑esteem or self‑confidence.
There
is no a priori reason to believe that women who decide to undergo breast
augmentation have lower self‑esteem or are more depressed than women who
undergo liposuction or other plastic surgery procedures.
Interestingly,
while breast implant manufacturers attribute suicide excess to pre‑implant
psychiatric disorders, they also maintain that implants improve a woman's self‑worth. There are no studies to support this
assertion either.
The
bottom line is that every published study on suicide and breast implants shows
that there is an increased risk of suicide.
The question is why.
No
prospective study of depression before versus after augmentation has yet been
reported. No study has yet examined
post‑surgical outcomes among patients who later completed suicide. Well‑designed, case‑controlled
psychological autopsy studies are needed to make differentiations and/or links
between preoperative and postoperative risk variables.
Thank
you.
CHAIRMAN
CHOTI: Thank you.
Good
morning. Next?
MS.
HOUSER: Good morning. My name is Christie Houser. I have no conflicts of interest. I'm a 47‑year‑old mother of 2
boys and a full‑time first grade teacher's assistant. I got silicone implants for augmentation at
age 25. I researched my particular
implants and was told by every doctor that everything would be fine and that
the implants would outlive me.
Everything
was great for a while, but after five years, I started experiencing joint
problems, flu‑like symptoms, rashes, and a cough that wouldn't go
away. The doctors told me that the
symptoms could not be related to the implants.
And I believed them and trusted them.
The
implant makers will present four years of studies tomorrow. If I had been included in these studies,
most of my problems would not have been seen.
We must have real long‑term studies to truly evaluate the safety
of the product.
Silicone
implants have been on the market for 40 years.
Yet, the industry has never presented more than four years' worth of
data. Why is that? What are they afraid of? I believe we need to ask the long, hard‑term
questions.
Eventually
my health got so bad that I had an MRI and an ultrasound. They found that there was something behind
my left breast, but they couldn't really see exactly what it was. The implant was covering it. So they couldn't really tell.
When
they removed my implants ten years after augmentation, the outer coverings of
both of my implants were gone. There
was a golf ball‑sized cyst behind my left breast, which they could not
see with an MRI or ultrasound. And both
implants were ruptured.
They
removed the implants and as much silicone as they possibly could and sewed me
up. After two months of the surgery, I
noticed that my scars were not healing and they were tender. I went to the doctor, and he told me that it
would take time to heal.
I
went to another doctor. And he saw
something that was trying to come out of the scar. In fact, it was silicone that was leaking out of my scars in
places that were not healing.
I
have two sons. They both have diseases
that are unusual. My 16‑year‑old
son has Hashimoto's thyroid disease, which is typically found in adult women
over 30. My eight‑year‑old
has something called urticaria pigmentosa, which is a cafe au lait spot that
can blister and previously has put him in anaphylactic shock.
There
is no evidence showing that my son's illnesses are through breast‑feeding,
but it does beg the question. How did
they end up with these strange diagnoses?
There
are too many unanswered questions to approve this product. The American people look to you to guide
their health and their children's health.
I am not against implants, but if we do not demand the research to
determine that silicone implants are safe for long‑term use, we have to
answer a new generation of women and their children with serious, serious
health problem.
Thank
you so much for listening.
CHAIRMAN
CHOTI: Thank you.
MS.
VAN FOSSEN‑NYE: Good
morning. My name is Kathleen Van Fossen‑Nye. I drove here from Sinking Spring,
Pennsylvania to speak before the panel.
And I have no conflict of interest.
I spoke before the panel in October of 2003.
My
history with silicone breast implants is almost as long as the products have
been on the market. In 1968, when I was
22 years old, I was implanted with the original Cronin implant following a
bilateral mastectomy for a precancerous condition.
A
military doctor performed my first breast implant surgery because my husband
was in the U.S. Navy. In the government
lawsuit, manufacturers agreed to pay five government agencies, including the
Department of Defense, the Department of Veterans Affairs, Medicaid, and
Medicare, millions of dollars to reimburse them for the costs they incurred
treating women made ill by silicone breast implants. This settlement demonstrates that the federal government is aware
and has acknowledged that silicone breast implants cause health problems and
disabilities.
However,
how can the FDA even consider approving these PMAs when the Department of
Health and Human Services has already made it clear that silicone breast
implants pose a serious health risk to women, costing millions of dollars?
In
the past, I have heard the panel members ask why so many women get breast
implants and why they keep getting them, even after they fail? I have heard plastic surgeons on the panel
say that the women don't mind the complications because they really like their
implants. This was not true for me.
I
started to suffer from fatigue and joint pain, and the implants were hard and
painful. I went to a number of plastic
surgeons, asking to have my implants removed.
I found a plastic surgeon who was willing to remove the implants. He removed and replaced my implants with a
new and improved implant. This started
my journey through a silicone nightmare.
I
have experienced the gamut of problems, including outright rejection. Eventually necrosis developed, and the
implant actually came out through my skin and popped out on its own. Here is the photo of what happened.
Despite
my mastectomy, I developed breast cancer in '86. I have had a total of 15 implants and expanders over the
years. Why did I have 15 implants? I had so many because I believed my doctors
when they told me they were new and improved.
I wanted to believe my doctors when they told me they were new and
improved.
For
over 35 years, I have experienced new and improved implants. I have come to the conclusion there is no
such thing as a new and improved silicone breast implant.
CHAIRMAN
CHOTI: Thank you. Good morning.
DR.
GLICKSMAN: Mr. Chairman and members of
the panel, I am a plastic surgeon practicing in New Jersey for 15 years. I have not received any financial support
from any implant manufacturer. And I
traveled here at my own expense.
Before
I get to my statement, I have a quick comment regarding Dr. Olding's letter to
the panel. This development clearly
demonstrates that the FDA's review process is flawed. They have no backup plan and no provisions for an alternate
panelist. I now have serious questions
about the FDA's ability to conduct fair
hearing.
I
am testifying again, as I did in 2003.
And the question today should be what has changed since 1992. Now, clearly we have the evidence‑based
science to demonstrate the safety and efficacy of these implants. Over 15 years of study show no link exists
between silicone and systemic illness.
What
has changed in the last 20 years are the devices, the surgical techniques, and
the role of plastic surgeon as both physician and educator. And, most importantly, we now encourage the
shared responsibility of the patient to maintain good breast health by follow‑up
exams and replacement of their implants as necessary.
The
devices used today have evolved dramatically from those of the '70s and
'80s. I can tell you that the devices,
surgical techniques, and our preoperative patient evaluation have changed so
dramatically that my reoperation rate at five years is less than three percent.
But
what about the patients? How do you get
American women between 18 and 80 to choose a board‑certified plastic
surgeon to understand the concept that a breast augmentation is not just a boob
job and every pretty blonde does not have to be a D‑cup? Here's where a new generation of plastic
surgeons under a new generation of leadership has made their greatest strides.
Manufacturers
in the plastic surgery societies have in place courses that teach the
techniques that reduce the reoperation rates.
We have published algorithms that can help reduce the cycle of
reoperations for implant complications.
And we have created Web sites where American women can research their
choices and become fully informed of their potential risks and benefits of
implants, even before they step into a doctor's office.
Women
demand and deserve a better level of health care. No medical device lasts a lifetime. And technology now exists, such as MRIs, that can evaluate the
integrity of silicone implants as they age.
Even
with these changes, we cannot force American women to choose a board‑certified
plastic surgeon or return for follow‑up care, just as we can't force
adults to quit smoking, lose weight, or wear their safety belts. But we should not limit the use of an
implant that has been shown to be safe and effective in study after study because
it is used for aesthetic reasons, purely for the enhancement of a woman's self‑esteem.
No
different is it from drugs for erectile dysfunction. Their sole purpose is to improve a man's self‑esteem and
quality of life and were approved by the FDA without controversy.
As
a plastic surgeon, I have performed thousands of implant surgeries using both
silicone and saline. I have found
silicone to be safe and effective and far superior.
In
1876, William Welch, the founder of Johns Hopkins Medical School said, "In
the end, our preconceived beliefs must change and adapt themselves." The facts of science will never change. I base my medical decisions on fact, and the
FDA should do the same.
I
urge the panel to make a determination on evidence‑based science, not
politics and emotions, and leave the choices up to individual women and their
physicians.
CHAIRMAN
CHOTI: Thank you.
Next
speaker?
BETH: My name is Beth, and I have no conflict of
interest. To protect my family's
privacy, I thought long and hard about whether I should come and testify
today. I decided that because of my
concern for children born to implanted mothers, I would come at my own expense
to tell you how I became convinced that the platinum and other toxic chemicals found
in breast implants have harmed my health and that of my two young daughters.
For
privacy, I will refer to them as "Muffin." She's seven.
"Stinkerbelle" is nine.
Both of my girls have tested for lupus due to their extremely high
platinum levels, especially Muffin. We
have been told that her bones are deteriorating. Here is my story.
After
ten years of implantation, a chronic cough caused my right implant to herniate
outside the scar tissue. Due to
numerous symptoms, including hair loss and swollen lymph nodes. My implants were removed in '92 without
replacement.
Two
years later I became pregnant with my third child, then my fourth. I was plagued with autoimmune symptoms
during these pregnancies, swollen lymph nodes throughout my body, and weight
loss. I was so ill in this last pregnancy
with Muffin that my doctor informed me that she was living off my body fat.
Published
research shows that platinum is stored in the fat of breast‑implanted
women. I am convinced this is why
Muffin has an even higher lupus score than I do. And even her platinum level is higher than mine, so high that I
cannot say it out loud at this hearing.
I
also understand that ionized platinum can cross the placenta. And significant levels of platinum are found
in breast milk. I breast‑fed both
of my daughters.
Since
that time, my health has deteriorated.
Some of my symptoms and diagnosis include asthma, photosensitivity,
hives, throat swelling, and lupus, lung and bone pain.
My
two children born before I had implants are very healthy, while Muffin and
Stinkerbelle are constantly reacting as if they have multiple allergies when
they have none. They endure bladder
problems, photosensitivity, eczema, intense bone pain that wakes them up in the
night screaming, lung pain, asthma, chronic pneumonia. Their lives and health have been forever
altered.
As
a mother who faces an unknown future for health consequences for herself and
her young daughters, I ask you to vote no on this PMA application.
CHAIRMAN
CHOTI: Thank you.
Good
morning.
MS.
SHEPPARD: Good morning. My name is Audrey Sheppard. I live locally and have no financial
conflicts.
For
four years, 1996 through '99, I directed the FDA Office of Women's Health. As a result of my professional involvement
with silicone breast implants, I regard sharing my perspective an ongoing
responsibility. I hold the agency and
you in high regard and am optimistic about your making scientifically sound
judgments.
My
role at OWH, nearly a decade ago, requested by and partnering with the Center
for Device Leaders, was to chapion and obtain full funding to conduct what
became the critically important FDA rupture study. Its findings have resulted in a better understanding of the
frequency of these devices rupturing over time.
You
will be briefed ‑‑ and there has been reference to it already ‑‑
on the results. Suffice it to say that
over time more than 65 percent of women in the study were found to have at
least one ruptured implant and over 21 percent had silicone gel outside the
capsule in one or both breasts. The
latter finding is particularly concerning since the effect of silicone on the
tissues and in development or progression of disease remains unknown.
After
leaving the agency five years ago, I have advised and assisted women's health
and other women's nonprofits and projects and from this vantage point will
share three requests. One, follow the
science.
Even
the company's data, which you know will put on the best face, will not dispute
a significant rupture rate nor other consequences of having these devices for
years. These are not lifetime devices
and, as such, without regular and too frequent resurgeries are not safe and
effective, as intended.
Two,
pay close attention to FDA's own documents and data. A number of documents on the CDRH Web site, including ‑‑
and I have the names, but you can find them.
These themselves are damning information that is based on scientific
research, decades of experience, tens of thousands of adverse event reports. And it also includes disconcerting
photographs.
Please
don't discount this body of material with the argument that the devices are
much improved today. Make certain there
is data to prove it.
And,
number three, please believe your own eyes and ears when you see the dozens of
sincere women whose health has been compromised standing before you. Of course, you will also hear from those who
are highly satisfied. Their experience
does not provide reason enough to open implants to wide use for augmentation,
even by teenage girls.
To
summarize, the health and well‑being of some of America's women and girls
will be affected, even if they won't know it for years to come, by your
decisions.
Thank
you.
CHAIRMAN
CHOTI: Thank you.
Good
morning.
MS.
GREEN: I'm Bettye Green. I'm the President of African American Women
in Touch. And I am a breast cancer
survivor. And I chose reconstruction
after a mastectomy. However, I believe
breast cancer patients deserve more information than they are getting.
Fortunately,
there are many more options than there used to be for breast cancer
patients. More than three out of four
are eligible for lumpectomy. So
relatively few women with breast cancer have a need to undergo a mastectomy in
the last few years or in the coming years.
And,
fortunately, women who undergo mastectomies have two other alternates to
silicone breast implants. They can
choose saline breast implants, which have a lower complication rate and are
easier to remove when they break, or they can choose an autologous tissue
transfer, a very popular procedure that moves tissue, in fact, from the abdomen
or other areas to create a breast that is much more natural looking and feeling
than a breast implant reconstruction.
Over
the years, FDA panels have heard from some breast cancer survivors about the
mental health benefits of silicone breast implants for mastectomy patients who
want to reconstruct their breasts, but now that there are so many choices, do
silicone breast implants offer benefits that are greater than other options, so
great that they are more important than safety?
Research
by Dr. Julia Roland of the National Cancer Institute and her colleagues found
no difference in the quality of life of women who underwent lumpectomies, women
who underwent mastectomies, and women who have had mastectomies with
reconstruction.
Even
more surprisingly, the women who had reconstruction felt their sex lives had
been harmed more than mastectomy patients.
If we look at the data presented by Inamed and Mentor, these findings
make sense.
Most
reconstruction patients require a lot of complications. They report more autoimmune symptoms two
years after implants, such as joint pain and mental confusion, compared to
before getting breast implants.
According
to a study of women who had reconstruction five years earlier, most implant
patients were no longer satisfied. In
contrast, most of these autologous tissue transfer reconstruction patients
remain satisfied. The implant makers
remind us that their studies show that patients are satisfied.
But
as a cancer survivor, a nurse, and a leader of a national group for breast
cancer patients, I can tell you that most breast cancer patients don't tell
their plastic surgeons that they are unhappy.
They have been through cancer.
Most don't like to complain about how they look now, especially in a
study when being honest will not help them in any way and could potentially
harm their relationship with their doctor.
I
have another concern that nobody has mentioned and that is very important. There are very few African American women or
Asian American women in the Inamed or in the Mentor study. For example, there are only six African
American breast cancer patients in the Inamed core study and only five Asian
American women.
This
is a big problem because African American and Asian women are more likely to
develop a cheloid scarring. This
scarring tendency could potentially increase the risk of capsular contracture
as well.
African
Americans are also at an increased risk of autoimmune diseases. So it is essential that silicone gel breast
implants not be approved until they are carefully studied on women of color.
In
summary, research suggests that women who have had reconstruction after
mastectomy do not have a higher quality of life than women who do not undergo
mastectomy. Their sex lives seem to
suffer more, not less.
Independent
researchers found that the majority of implant reconstruction patients are not
satisfied five years later. These
findings are more credible than those funded by implant companies.
In
one study, reconstruction patients were ten times as likely to commit suicide
as mastectomy patients who do not undergo reconstruction. More African American and Asian American
women need to be included in breast implant study, especially studies of breast
cancer patients. Neither Inamed nor
Mentor have studied enough women of color to determine if the risks are any
different for them compared to white women.
Thank
you so much for listening.
CHAIRMAN
CHOTI: Thank you, Ms. Green.
Next? Yes?
MS.
KUECK: Good morning. My name is Jana Kueck, and I'm a registered
nurse from Branson, Missouri and a sister of an injured breast implant
consumer. I've been a registered nurse
for 21 years. My background includes
labor and delivery, newborn nursery, and assisting new mothers as a former
breast‑feeding educator. I have
no financial relationship with the PMA sponsors, their products, and their
competitors.
Numerous
studies have found that breast‑feeding provides newborns with essential
nutrition and improved resistance to infections. By impeding or preventing breast‑feeding, implants have
become a public and pediatric health problem as they are essentially depriving
newborns from these benefits.
According
to the Institute of Medicine, any kind of breast surgery, including breast
implant surgery, makes it three times more likely that women trying to breast‑feed
will have inadequate milk supply or lactation insufficiency.
In
a study conducted by Marianne Neifert and colleagues of the University of
Colorado at Madison, women who had breast surgery were three times more likely
to have lactation insufficiency than those that did not have surgery. The doctors compared the rate of weight gain
of breast‑fed infants born to mothers who either did or did not have
previous breast surgery. Mothers whose
babies did not gain at least one ounce per day or required supplemental
feedings with formula were deemed to have lactation insufficiency.
Interestingly,
the women who had breast surgery through an incision in the nipple area or
periareolar incision had a higher incidence of problems. Those women were more likely to suffer from
insufficient milk supply.
I
frequently have observed decreased milk production in mothers of breast‑implanted
surgery. In addition, implanted
mothers' infants also had difficulty latching onto the breast due to the
firmness, usually caused by capsular contracture, even a mild contracture, from
the implants.
We
don't know how silicone breast implants affect what is in the mother's milk,
but it is certainly worthy of more study.
Recent research suggesting platinum in breast milk due to the platinum
used as a catalyst in silicone breast implants concerns me a great deal.
Because
of what is known and what is yet not known about the risk of implants on breast‑feeding,
I am asking you to vote against the approval of Mentor's and Inamed's
application. Voting against approval
will support women's health and the health of precious newborns.
CHAIRMAN
CHOTI: Thank you.
Next? Good morning.
DR.
GOLDBERG: Good morning. Thank you for the opportunity to highlight a
few scientific issues pertinent to the panel's review of gel implant safety.
I'm
Eugene Goldberg. I direct the
Biomaterials Center at the University of Florida. I have no financial interest in breast implants. I traveled here at my own expense.
My
group has conducted research on the biocompatibility of silicone implants for
more than ten years. In addition to my
comments here, I have appended more information for you.
We
published the only large cohort clinical evaluation of gel implants. This is a meta analysis of about 10,000
implants from 42 different papers. A
high prevalence of rupture and additional surgeries was found. A plot of failure versus time showed 29
percent of rupture at 5 years and 70 percent of rupture at 17 and a half
years. When the next slide comes up,
you will see that.
One
of every three women with implants required additional surgery within six years
due to pain, hardness, disfigurement, or rupture. In an FDA‑NIH study using MRI plus explant surgery, Brown
and coworkers confirmed our results.
They found 69 percent rupture at 16 and a half years. And that falls directly on our implant
rupture curve that is shown up there.
A
Mentor consultant states that "Rupture is a critical safety
parameter," but Inamed in a letter to the FDA says that rupture is
"an unintended patient outcome."
Frequent additional surgeries are truly also unintended, but both pose
major safety risks.
Inamed
now tells us that surgical damage is the leading cause of failure. If so, why aren't gel implants properly
designed for normal surgical procedures?
Inamed's 4‑year clinical results show still a high 10‑22
percent rupture, despite a presumably thicker shell with phenyl siloxane as a
barrier. Short‑term rupture is
actually not much lower than reported before.
Also
note that crazing and cracking of phenyl siloxane coatings can occur after four
to five years. And the barrier
properties and strength may deteriorate as a result after five years. Four‑year clinical data are not
adequate.
Finally,
an increased risk for cancer of the lung, cervix, and brain is reported for gel
implant recipients. It is simply not
reasonable for Inamed to blame this on lifestyle with no scientific
evidence. This is another potentially
serious problem, and it must be resolved.
Thank
you.
CHAIRMAN
CHOTI: Thank you.
Good
morning.
DR.
WOOLEY: Good morning. I'm Paul Wooley. I'm Professor of Orthopedic Surgery, Immunology, and Biomedical
Engineering at Wayne State University in Detroit. I have no financial ties with the sponsors or any of their
competitors.
I
would like to address the issue of latency and, in particular, the adjuvant
effects of silicone. My group has been
studying this for about a decade.
The
hypothesis that we address is that silicone as a rather sticky substance,
proteins, normal proteins of the body, can adhere to silicone. And minor conformational changes in the
protein can result in the development of autoantibodies. And such autoantibodies may be significant
in the pathology of connective tissue disease.
I
have four publications in leading journals on the subject. And I would like to update the panel on the
studies that we have conducted since they last met.
In
our early studies, we demonstrated that silicone implantation in mice did
result in autoantibodies, but those autoantibodies did not alter the disease
process in either arthritis or lupus.
However, our third study clearly demonstrated in a long‑term
implantation in mice that disease was indeed exacerbated.
To
take those studies to the human, we studied VP shunts in children and
demonstrated adjuvant effects with the development of an autoantibody that was
associated with an increased revision rate.
However, the data that I have made available to you today is the first
study that we have done in silicone breast implant material.
Paired
samples of breast explant material, silicone explant material, and sera were
made available to us from Dr. Fred Miller and Terry O'Hanlon at the NIH. These were provided in a blinded manner. We did not know which sera went with which
breast implant, and we did not know the diagnosis or reason for the
explantation.
Three
of them it turned out the patients had either an autoimmune or a connective
tissue disease. Three of them were
clinically normal at the time of explanation.
We
used a published and recognized method of removing the proteins from the
silicone surface and we used the sera in a Western blot assay to assess whether
the patient has a reaction against any of the adherent proteins.
Our
findings were we believe quite significant.
A novel 205‑kilodalton protein was removed from the surface of
these explanted materials and was found to be immunologically active.
It
turns out that this ‑‑
CHAIRMAN
CHOTI: If you could sum up, please?
DR.
WOOLEY: Yes.
‑‑
that this protein was associated with either MGUS or mixed connective tissue
diseases. However, the antibody to that
protein was also detected in patients who were clinically normal at the time of
explanation. This antibody is not
present in normal women.
Thank
you.
CHAIRMAN
CHOTI: Good morning.
MS.
HEIDE: Good morning. My name is Terry Heide. And I'm reading a statement on behalf of a
patient who couldn't be here today.
"My
name is Nancy Reuben Greenfield, and I am sorry that medical issues have kept
me away from delivering this speech personally. I want to thank the panel for giving me an opportunity present my
support for silicone breast implants.
"First
I need you to know that Inamed Corporation generously and compassionately
sponsored my book, When Mommy Had a Mastectomy, which is designed to help
parents and children through the trauma of breast cancer and the process of
recovery.
"I
am actually not one to talk about breasts in general, let alone in public. I have always been a tomboy. I got a sports bra because I had to. But along the way, I became a woman and a
mother. And I will always consider
nursing my children as one of the true highlights of my life.
"When
I was 39, I got breast cancer and needed a double mastectomy. I wasn't sure what I would do after the
mastectomies. I decided staying flat
wouldn't suit me. And prosthetics are a
great idea, but I have enough trouble finding my keys. So I decided on breast reconstruction, and I
appreciated the fact that as a breast cancer survivor, I had the choice between
silicone and saline implants.
"My
plastic surgeon highly recommended silicone implants because his patients raved
about their comfortability and he saw no differences in terms of their safety.
"When
you have breast cancer and you have children, at some point you have to tell
them. My children were five and seven
at the time, and there was no book that could help me. So I decided to write one.
"Writing
it was easier than getting it published.
Even when I found a publisher, there were no funds available for the
project. It was then that my publisher
and I came up with the idea of asking the manufacturer of my implants if they
would be interested.
"Based
on my research, silicone has no worse or better effects on the body than
saline. Based on my personal
experience, my silicone implants are really comfortable.
"Frankly,
I don't really understand the FDA research on silicone implants. They are already on the market for breast
cancer patients. They have proved to be
safe. And women are very satisfied with
the results.
"Why
should breast cancer be the determining factor on the use of silicone
implants? It seems more like moral
judgment on why people choose to have implants, rather than an issue of science
and medicine.
"The
choice to have silicone implants shouldn't be a consolation prize after breast
cancer. Any woman who changes her
breasts, for whatever reason, should have the option to use silicone implants.
"I
ask you today to approve silicone implants for any woman who wants or needs
them. Let all women be treated
equally. Nancy Reuben Greenfield."
CHAIRMAN
CHOTI: Good morning.
MR.
GOOZNER: Good morning. My name is Merrill Goozner, and I am the
Director of the Integrity in Science Project at the Center for Science in the
Public Interest.
Integrity
in Science seeks to focus public attention on the issue of how financial
conflicts of interest are affecting the objectivity of the scientific process,
especially through federal scientific advisory committees, such as this one.
While
CSPI is largely self‑funded through its newsletter, the Integrity in
Science Project I run receives additional funding from several
foundations. None of these outside
foundations have a particular interest in this issue or, I might add, in
medical issues generally.
The
Federal Advisory Committee Act prohibits people with conflicts of interest from
serving on committees providing scientific advice. The logic behind this provision is that a person sitting in
judgment of a body of evidence should not simultaneously be employed by an entity
with a stake in the outcome.
The
law allows for an agency to grant waivers if a scientist expertise is deemed
necessary for the committee, which has happened in this case, a point I will
return to in a second.
The
law also requires that committees be balanced as to points of view, a recognition
that even when there isn't a direct conflict of interest, a person's outside
employment can influence their outlook on the questions at hand. The scientific literature is very clear on
the impact of financial conflicts of interest on the outcome of science.
With
this by way of background, allow me to address the makeup of this
Committee. This Committee is smaller,
yet similar, in makeup to the last committee evaluating the silicone gel breast
implants. Its permanent roster includes
Dr. Michael Miller.
According
to your own statement this morning, Dr. Miller's institution has received
$25,000 from Inamed, one of today's petitioners, for his role in producing an
educational CD‑ROM about breast reconstruction surgery.
I
have viewed video excerpts from that CD‑ROM. In it, Dr. Miller states, and I quote, "At this time, a
number of good studies have been completed and there are others ongoing that
show implants do not cause disorders, such as cancer or autoimmune diseases. Based on these studies, we are confident
that breast implants are safe."
It
would appear based on this evidence that Dr. Miller not only has a conflict of
interest but has a point of view about the evidence he is about to hear
regarding the safety and efficacy of these products.
The
purpose of waivers is to allow scientists to serve when their expertise is
deemed critical to the Committee's deliberations. In no way can Dr. Miller's expertise be considered unique. He is one of four plastic surgeons on this
Committee, which brings me to the second issue of concern about this makeup.
The
Federal Advisory Committee Act requires that committees be balanced. Eighteen months ago, after the last
committee voted nine to six in favor of allowing the silicone gel breast
implant on the market, with all four plastic surgeons on the committee voting
in favor, the chairman of that committee, Dr. Thomas Whalen, wrote then FDA
commissioner, Mark McClellan, decrying the committee's lack of balance. Specifically, he noted, "Even in
academic settings, plastic surgeons may stand to increase their own income with
the use of these devices."
Whether
one agrees with that statement or not, the fact is that the number of plastic
surgeons on this committee is double the number of physicians who treat the
diseases that might arise from the use of these devices. Where is the balance?
The
Center for Science in the Public Interest is extremely disappointed that the
FDA chose to overlook the conflicts of interest and has created an unbalanced
panel to evaluate the evidence on this issue.
The FDA has again created a situation where the final vote will be
clouded by the perception that some members had conflicts of interest that my
have influenced the vote.
CHAIRMAN
CHOTI: Thank you.
Good
morning.
MR.
COMPTON: Good morning. I'm Phil Compton, and I'm Community
Organizer for our Florida Consumer Action Network, a grass roots consumer
organization with more than 40,000 members statewide. I come here today with no financial ties to either sponsor or any
of their competitors.
Following
the October 2003 panel, the chairman of the advisory panel, Dr. Thomas Whalen,
took the highly unusual step of writing a public letter to then FDA
commissioner Mark McClellan. This is
the first time that a chairman of an FDA advisory committee ‑‑ and
there are literally hundreds of them spread over the 5 operating centers of FDA
‑‑ has written such a public letter in at least a decade. This letter was reported on the front pages
of major newspapers across the country.
For
the new members of the panel, here is what Dr. Whalen wrote, "Dear Dr.
McClellan, on October 14 and 15 of this year, I chaired the General and Plastic
Surgery Devices Advisory Panel in Gaithersburg, Maryland for consideration of a
PMA by Inamed Corporation for silicone gel breast implants.
"As
I am sure you are aware, the panel voted nine to six that this PMA was
approvable, and the matter is now under consideration for action at the
CDRH. I write to express as the panel
chair my very strong reservations concerning this vote, having thoroughly
reviewed the PMA, heard my scientific colleagues on the panel, as well as the
presentations of Inamed and the FDA, and having intently listened to all of the
over 100 individuals who gave public testimony.
"At
its essence and as is mandated by federal code, the mission of an FDA panel and
then the FDA itself acting upon the panel recommendation is really elegantly
simple: To judge that the company
bringing the PMA before them has demonstrated with reasonable assurance that
the product under consideration is both safe and effective. Effectiveness was
demonstrated and is almost self‑evident.
"Long‑term
safety, the concern that prompted the removal from the market 11 years ago, was
clearly not demonstrated. And to
approve this device poses threats to women that are clearly unknown.
"In
my opinion, there is at least one facet of long‑term danger that was
established during the panel:
Specifically the obscuration of surrounding normal breast tissue to mammographic
detection of breast cancer. The
reoperation rates and other local complications from silicone leaking outside
the breast area have also been established by FDA scientists and are not minor
considerations for a cosmetic device.
"Moreover,
despite the sophistication of the Institute of Medicine's report, all of what
was considered by them reflected low‑quality data in the age of evidence‑based
medicine.
"It
is incumbent upon the FDA to demand that the manufacturer establish in a
rigorous prospective, controlled study that these devices, despite their
established breakage and leakage rates, are safe in the long term. If that is deemed to not be feasible for the
company, then they should abandon pursuit of approval. However, the company's track record suggests
that they are capable of such research but have not been sufficiently motivated
to complete it.
"The
plethora of approval conditions that had my head spinning during panel
deliberations is proof that even those who voted the PMA as approvable are
deeply concerned about the lack of long‑term safety data on this
product. What will motivate the company
to follow these FDA requirements?
"Most
upsetting was when an FDA official admitted, at my pressing, that there is
little, if any, remedy for the FDA if demands to demonstrate long‑term
safety are not carried out by the company.
"I
need not point out to you in your position what the term 'FDA‑approved'
represents to our citizenry. Once this
horse is out of the barn, indeed for a second time, there will be no recourse.
"I
have the utmost respect for my colleagues on the panel, one and all. This most assuredly includes the four well‑respected
and knowledgeable plastic surgeons.
Certainly, it was essential to include board‑certified plastic and
reconstructive surgeons when considering a PMA on breast implants.
"On
the other hand, it serves the reputation of the FDA in general and the standing
of the panel process, in particular, exceedingly poorly to have had all of the
plastic surgeons vote the PMA as approvable on such a close vote. Even in academic settings, plastic surgeons
may stand to increase their own income with the use of these devices. To cite a worn aphorism, it just does not
play well in Peoria.
"In
closing, I must add that the issue of medical care of women who suffer
complications from these implants is extraordinarily troubling. Costs for removal of these implants and for
extra‑capsular silicone can be enormous and are very rarely covered by a
health plan. This is a public health
issue of no small import that must be addressed should the FDA second this
misguided panel decision.
"I
have been honored to be a part of the General and Plastic Surgery Devices
Advisory Panel these past few years, and have been extremely impressed by the
devotion and professionalism of those in your agency.
"I
regret that the final chapter of my FDA experience was this one and implore you
and Drs. Feigal and Witten to not approve this PMA. I would be delighted to provide any further information if you
desire it.
"Sincerely
yours, Thomas V. Whalen, M.D., Professor of Surgery and Pediatrics."
Now,
there are two questions each of you should ask. What did the Center for Devices and Radiological Health do to
find out what happened here and to correct it?
If FDA did nothing, then how can the agency expect to have an impartial
advisory committee meeting?
Thank
you.
CHAIRMAN
CHOTI: Good morning.
DR.
PARISIAN: Good morning. I'm Dr. Suzanne Parisian. I am speaking on behalf of Pro‑Choice
Alliance for Responsible Research. I
formerly was a chief medical officer for Office of Device Evaluation, Center
for Devices and Radiological Health at FDA.
I'm a physician. I'm board‑certified
in pathology. And I'm author of FDA
Inside and Out.
Thank
you for considering my testimony. I
have no conflicts of interest with any of the applicants or their competitors.
When
FDA denied Inamed's marketing application in 2003, it followed by releasing a
guidance document requesting ten years prospective data for primary
augmentation, reconstruction, and revision populations.
FDA
provided methods for mechanical testing, requested rupture rates, and longer
clinical studies, addressing areas which FDA indicated were critical to the
assessment of safety.
FDA
expressed concerns that implants were rupturing at unacceptably high rates,
that longer‑term health risks were still unknown, and silicone's effect
on the body was not yet fully studied.
Liquid
silicone injection has not been found to be safe by FDA in other application
reviews. However, industry routinely
dismisses FDA's requests for long‑term data and continually ignores all
the safety concerns.
On
average, women begin to report problems with their breast implants at seven to
ten years after implantation.
Therefore, three to four‑year studies with clinical data are not
adequate to assess safety. We still do
not have the adequate long‑term safety data for silicone breast
implants. The manufacturer's
application should be denied.
FDA
first requested this safety information for silicone breast implants in 1988
for products that had already been on the market 20 years. Instead of science, valid data, and a
concern for women's health, FDA continues to be met with well‑financed
and well‑organized resistance. If
FDA cannot compel PMA sponsors to provide the adequate long‑term safety
data for silicone breast implants before PMA approval, it will never be
obtained.
Improved
manufacturing practices, quality controls, and informed consents have been
instituted through the efforts of CDRH's staff. I know that. And this is
for both the saline‑filled and the silicone gel breast implants.
I
know that sponsors tell FDA that the women are lost to follow‑up for long‑term
data because they're too embarrassed to talk about their silicone breast
implants with the companies. Yet, these
same sponsors can find these women in order to finance their breast implants
and make payments or they can suddenly locate data in Europe that they didn't
have before.
Although
there are many inadequacies in these PMA applications, time only permits me to
make four brief and important points.
First, neither Inamed nor Mentor have come up with reliable safe rupture
rates. They have come up without good
methods to detect rupture rates. And
their data does not reasonably predict the safety profile for each device over
its lifetime.
According
to the FDA analysis of the industry data, three‑quarters of implanted
women will have at least one ruptured implant within ten years of receiving the
devices. Specifically, FDA has
estimated that up to 93 percent of breast cancer reconstruction patients should
receive at least one broken implant.
They will have, will expect to have, not receive.
Second,
FDA should have the PMA sponsors obtain information about the children. As we have been hearing, the children have
been left out of the guidance document.
And we need further information about what happens to the children born
to women with silicone breast implants.
No woman would want to have a cosmetic surgery and then hurt her
children. And these products will be
aggressively marketed to women, young women.
Now implants are being put in women younger than 18 years of age.
Third,
implants can obscure mammographic imaging by hiding the breast tissue. MRIs have been set as an alternative
technology to screen these women, but they're not always accurate. MRI doesn't always detect rupture in these
women. And there's conflict between
rupture and explants.
Additionally,
it has been very misleading to the public to imply that MRI facilities are
trained, willing, or can be reimbursed for these types of studies. The average cost of an MRI is $1,890. So a recommendation that women receive MRI
is not inconsiderate in terms of expenses.
And also, young women do not routinely receive any kind of imaging.
Fourth,
FDA's approval, as I know, is the gold standard for the American consumer. After the 2003 FDA panel meeting, FDA
determined that silicone breast implants were unsafe. The long‑term effects still have not been adequately
addressed by either sponsor as they continue to ignore FDA guidance. You still do not have that safety data that
you thought was necessary 20 years ago.
So please do not recommend approval.
Thank
you very much.
CHAIRMAN
CHOTI: Good morning.
MS.
BAEKE: I am Suzanne Baeke. I am a registered nurse, patient educator
specializing in plastic surgery. I have
no financial ties with any of the breast implant manufacturers.
I
chose to have breast implants seven years ago.
Three years later, my life with silicone gel breast implants would be
best described as the roller coaster ride from hell.
Each
day brought with it new horrors: fevers
up to 103, chills, memory loss.
Concentrating on everything became a problem, hair loss, repeated
bladder infections, zero sex drive, dry mouth, severe joint pain, painful feet,
and crippling muscle spasms to the point where I had to have three deep tissue
massages per week.
The
mood swings were crippling, not just for me but my entire family. At times I wished I were not alive. I suffered the chronic fatigue, yet suffered
from insomnia. I would at times have to
pull into a parking lot and shut my eyes for what I thought would just be a
minute but turned out to be 45.
I
was evaluated by my rheumatologist at the Mayo Clinic for chronic fatigue
syndrome. MS, fibromyalgia, ankylosing
spondylitis were all considered.
Members of the Committee, I would not have wished my life on anyone, but
I refuse to give up. I refuse to live
this way. And I was on a mission to
find out what was wrong with me.
I
bought every product on late‑night television that promised to fix
me. Eventually I found an
endocrinologist, Dr. Bernard Rice. He
performed on me the most comprehensive evaluation I had ever witnessed. Eventually he took me by the hand, took my
husband, and said, "Your wife needs hormone replacement. The fact that you are still married is
incredible. Most men get out when
things get this bad."
Dr.
Rice is one of the pioneering investigators in the gradual but debilitating
effects of hypo‑ovarian syndrome.
Call it premenopause if you wish.
All women begin to suffer the effects of low ovarian testosterone
production early in life, progressing until full menopause. For me, the hysterectomy with an
oophorectomy sped up this insidious process.
Distinguished
panel, I am here to set the record straight.
It is no coincidence the symptoms of which I suffered are identical to
many of the women testifying today. I
submit that silicone implants have been ridiculously maligned when more likely
the culprit is the low testosterone levels in the pre‑menopause and
menopause patient. With expert estrogen
and testosterone replacement, all of my symptoms immediately reversed. And I still have my silicone gel implants.
To
the National Organization of Women, I challenge you. If your motives are truly honorable, consider that you may be
wrong. Read my lips. The real problem afflicting millions of
women is not silicone gel implants.
It's, rather, inadequate hormone replacement therapy.
Thank
you.
CHAIRMAN
CHOTI: Good morning.
DR.
BAEKE: My name is Dr. John Baeke. I am a plastic surgeon with extensive
knowledge regarding silicone gel breast implants. I have no conflict of interest.
Second
slide. Please review my data carefully,
paying close attention to my low complication, reoperation, and zero deflation
rates. I provided full handouts out in
the hallway for each one of the panel members.
And I invite you to please pick up one.
After
the 2003 hearings, I was disheartened by the dearth of testimony supporting the
elective cosmetic surgery patients. I
will not be shy in standing up for these women. Organizations like NOW too often portray women desiring breast
enhancement as bimbos. Shame on
you. The cosmetic patient is typically
careered, in her 30s, seeks multiple opinions, is well‑versed on the
subject, and on average requests only one and a half cup size increase.
Slide. Surgeons performing breast augmentation do
so not out of financial motivation.
Those guys can be found next door at the Botox hearings. If we were purely profit‑motivated,
cheaper, wrinkle‑prone saline implants would suffice. As plastic surgeons, we are committed to
providing women with the most beautiful breasts possible. And that requires silicone implants. If not for that simple fact, we'd all go
home.
Slide. How extraordinarily hypocritical, if not
insulting, to allow silicone implants for the cancer survivor but not for the
cosmetic patient. To the mastectomy
patient, the message is, "You're going to die of a disease anyway. So who cares?" To the cosmetic patient, the message is,
"Your plight is not to be taken seriously." It is arrogant for anyone to believe a small‑chested woman
is not experiencing real pain because of her developmental misfortune.
Slide. What a double standard for feminist groups
to promote a woman's right to choose when it comes to issues of abortion but
not to embrace that same freedom when it comes to silicone implants.
Slide. Why is mere dozen‑word warning
appropriate for cigarettes; yet, for silicone implants, the bar is set higher?
Slide. Shame on the naysayers for the hypocrisy of
condemning Inamed for presumed insufficient data. Remember, the core and adjunct studies that criticized were
designed with the oversight of the FDA.
At the same time, these individuals have become masters of the
melodrama, presenting volumes of purely anecdotal, nonverifiable, oft
exaggerated quips before this esteemed Committee without ever undergoing any
type of similar scientific scrutiny.
Does
it stand the test of logic that surgically removing implants would lead to
sudden improvement in symptoms when this is supposed to be a disease caused by
systemic‑wide dissemination of silicone?
Slide. One simple answer to this dilemma should
satisfy all. Legislate a standardized,
comprehensive informed consent. Require
its usage by all. Then trust the
sanctity of the patient‑physician relationship.
Slide. Since no one else will stand up and say it,
I will. Companies like Inamed should be
commended for the millions they have invested in research and development. The modern‑day silicone implant is
safe to the satisfaction of medicine and science alike. Thank you, Inamed.
MS.
CUMMINGS: Good morning. Ladies and gentlemen, my name is Arlene
Nicole Cummings. I came here at my own
expense today to tell you about how breast implants have affected me.
At
the age of 12, I had a breast tumor removed from my right breast. This left me with an asymmetry problem that
only got worse as I got older and had my children.
Fixing
my breast was something I had thought about for years. After I was done having my children, I felt
the time was right. I did a lot of
research online and found a great deal of information but nothing
personal. This is what prompted me to
start implantinfo.com back in 1998, after my own surgery.
Implantinfo
is now the largest community Web site for breast augmentation patients where
women can research the good and the bad about breast implants and go through
photos and stories of thousands of other women.
I
am here today primarily because I am a satisfied breast augmentation
patient. However, I never had the
option of choosing silicone back in 1998.
After years of talking to women and doing my own research, I now believe
silicone is a superior product in many ways.
If I had the option today, I would choose silicone over saline.
On
my Web site, I have corresponded with countless women who, for many reasons,
probably should have had the silicone option but did not. They were denied silicone implants, had an
unsatisfactory result with saline, and then had to have a second surgery to
replace their saline implants with silicone.
So they actually had to have two surgeries to get the result they wanted
the first time.
I
am also aware of the frustration surgeons feel because they cannot give a
patient what they know in some cases will produce a better result for them.
The
risk of a second surgery in my opinion is far greater than any silicone implant
would have posed. Ironically, breast
cancer patients already have compromised immune systems but for the most part
can receive silicone implants.
Are
they at less of a risk of the supposed risks of silicone breast implants? I believe silicone implants provide a far
better result for reconstruction. If
these patients get better results with silicone implants, shouldn't they be
available to all of us? Women along
with their surgeons should be allowed to choose silicone or saline. We are neither ignorant nor shallow, and we
are not seeking breast augmentation without informed consent.
We
have researched the procedure for years.
The average age of a woman on my Web site is 34. Most of us are married with children and
just want to get back what we lost after pregnancy and nursing.
I
believe in informed consent. And women
should know all of the risks. But in
the end, after we review that information, let us decide along with our
surgeons silicone or saline.
I've
received dozens of e‑mails from women who wanted to be here today in
person but could not for many reasons.
There are thousands of women like me on implantinfo.com. And I encourage you to come to the Web site
to read more about us and to give us both the choice of silicone and saline.
Thank
you for your time.
CHAIRMAN
CHOTI: Thank you.
MS.
COLOMBO: Good morning. My name is Michele Colombo. I am 36 years old, married, and I have one
child. And I come here at my own expense.
For
many years, I was dissatisfied with the size and appearance of my breasts. I am a very self‑confident and
educated person, but I have always seriously considered improving my appearance
by undergoing breast augmentation.
I
researched breast augmentation for approximately five years, including reading
the FDA Web site as well as other resources on the internet. In doing so, I satisfied myself that
silicone implants are a safe alternative for my breast augmentation.
Due
to a vocal minority in the early 1990s, silicone breast implants were banned
for sale to most ordinary people, like me, in the United States. If I lived in Europe, I could get silicone
breast implants without any question.
If I traveled to Europe, I could get silicone breast implants and I
could come back to the U.S. and live here with them, even though they're
unavailable here. If I had breast
cancer, I could get silicone breast implants, perhaps because those with breast
cancer are less prone to the purported risks of silicone breast implants.
What's
more, if I were a man, I could get silicone testicular implants. And if I required shunts for medical
reasons, it would also be made of silicone.
Fortunately
for me, in an ironic way, when I was seeking breast augmentation options, I was
able to qualify for silicone implants because I have a congenital
deformity. What does not make sense to
me is that silicone breast implants have been shown in numerous studies to have
no more long‑term health risks than saline breast implants and other
silicone devices.
Despite
the fact that the FDA up until now has allowed some people to get silicone and
not others, I don't understand why someone else can decide that they are safe
for me or for a cancer patient but not safe for someone else. In other words, a woman can make a decision
about safety of breast implants if they have cancer but not if they simply want
to improve their physical appearance.
I
am here to tell you that the benefits to women, regardless of whether they have
cancer or some other arbitrary qualifying factor, are equal. My life has improved dramatically since I
had my surgery last year. My sense of
self has improved. And it has affected
aspects of my life too numerous to mention.
I had a child after my breast augmentation with silicone breast implants
and breast‑fed him successfully.
I
think it is time to reevaluate the true motivation for the ban on silicone
breast implants. The fact that breast
cancer patients may obtain them and cosmetic patients cannot exposes the true
reason for the ban. What is at stake is
a moral judgment, rather than a medical one.
If
my breasts are completely deflated from breast‑feeding, weight loss, or
age, improving my appearance with breast implants is deemed unacceptable
because it would be for vanity. If I
had a mastectomy, it would be acceptable because it could be justified as medically
necessary, although many women choose not to get implants after mastectomy.
The
difference is a moral one, not a medical one.
I don't believe the FDA is the right organization, if any, to determine
what is morally appropriate to do to our bodies. If the FDA is going to ban silicone implants based on
unacceptable risk, I think it is time to ban all medicines which have side
effects.
Why
is my psychological desire to improve my appearance less important than the
desire of others to curb their appetites through approved weight loss drugs,
reduce heartburn, stop hair loss, et cetera?
The truth is it's just as important.
I
urge you to remove the ban on silicone breast implants and let women make
informed decisions about their bodies the way millions of people do every day
with countless other devices and medicines approved by the FDA.
Thank
you for your time.
CHAIRMAN
CHOTI: Thank you very much.
And
at this point, we'll take a break of about 15 or 20 minutes. Let's resume promptly at 10:30. Thank you.
(Whereupon,
the foregoing matter went off the record at 10:10 a.m. and went back on the
record at 10:39 a.m.)
EXECUTIVE
SECRETARY KRAUSE: I think we are about
ready to start. AnnMarie is here. Okay.
I am going to turn the meeting back over to Dr. Choti.
CHAIRMAN
CHOTI: Good morning. May we have our next public speaker,
please? Remember, you have three
minutes. And, just to remind you again,
the yellow light comes on with a 30‑second warning. And you need to stop by the time the red
light is on.
MS.
CORBETT: Actually, I'm representing an
organization.
CHAIRMAN
CHOTI: Okay. So five minutes.
EXECUTIVE
SECRETARY KRAUSE: Are you Christianne
Corbett?
MS.
CORBETT: Yes, I am.
EXECUTIVE
SECRETARY KRAUSE: Okay.
MS.
CORBETT: Yes. Good morning. My name is
Christianne Corbett. I am the Program
Coordinator at the National Council of Women's Organizations, NCWO. NCWO is am umbrella group for 200 women's
groups. And I am speaking on behalf of
the over ten million women nationwide that NCWO represents.
NCWO
is very concerned about the safety of medical products used by women. The key question for this FDA advisory panel
is whether silicone gel breast implants are safe, whether the benefits outweigh
the risks.
In
my testimony, I will focus on what we know and don't know about long‑term
safety. We know from hearing testimony
of the women at the 2003 panel meeting and again today that many of these women
were very happy with their implants for the first few years. But after seven or more years, especially
after their implants broke and started to leak, many women reported serious
problems.
Local
complications are the best established problems. These complications can be short‑lived, like most
infections, or can be devastating.
Chronic pain is very difficult to live with.
Having
breasts that are hard as rocks is not a goal for most women. And if things go wrong and implants have to
be removed, then what happens?
I
have some photographs that I want to share with you. The photograph up right now is a photograph of a 29‑year‑old
woman who had her implants removed after 7 years. She had capsular contracture that was so painful that she decided
to have her implants removed. This
photograph is from the FDA website.
Here
is another woman ‑‑ you can go to the next slide ‑‑ who
wasn't so lucky. This woman's ruptured
implant had leaked into her healthy breasts.
And when the silicone was removed, that is all that was left of her
breasts.
Now
let's look at some long‑term studies of diseases. The National Cancer Institute looked at
thousands of women who had implants for at least eight years. They found women with implants were twice as
likely to die from brain cancer, three times as likely to die from lung cancer,
and four times as likely to commit suicide compared to other plastic surgery
patients.
FDA's
scientists did the best study of the health of women with ruptured silicone
implants. All the women in their study
had breast implants for at least six or seven years. So some had implants that had been leaking for several
years. They found that women with
implants that leaked outside the scar capsule were significantly more likely to
report fibromyalgia and several other painful connective tissue diseases.
Dow‑Corning
paid for another study on ruptured implants, referred to as the Danish study in
the FDA review that was provided to you.
Unfortunately, the Danish study included only 23 women with implants
that leaked outside the scar capsule.
They found that those women had more pain and other problems than women
whose implants were not leaking, but because of the small sample size, those
differences were not statistically significant. The study is not conclusive because the number of women with
extracapsular leakage is much too small.
Implant
makers often say that there are more than 100 studies of women with implants
and that these studies prove that implants are safe. When they say this, they tend to ignore the studies that don't
agree with them, which tend to be the studies of women who had implants the
longest, such as the FDA and the NCI studies.
Most
of the studies that the implant makers quote as proving safety were funded by
Dow‑Corning. Almost all of the
studies in the often‑quoted Institute of Medicine report, including the
Mayo Clinic study and the Harvard study, were funded by Dow‑Corning. And, like the Danish study I mentioned, they
tend to have rather small samples. And
most studied women who had implants for a short period of time. For example, the Mayo Clinic study included
only 749 women with breast implants, and only 375 of them had had implants for
more than 7 years.
Autoimmune
diseases take years to develop and be diagnosed. And the sample would have to be larger to adequately study
diseases that are so rare in young women.
You don't have to take my word for it.
The authors point that out themselves.
Listen
to the testimony you will hear from the women today. It took years for them to develop diseases after getting their
silicone implants. First, they had
symptoms that they didn't take very seriously.
When they were tired or their joints
hurt or they had trouble concentrating, they thought that perhaps they
just weren't getting enough sleep or they were working too hard.
Those
are the same symptoms reported by Inamed in their patients who had implants for
only two years. They aren't sick or
diagnosed with diseases like rheumatoid arthritis, but it will take at least a
few more years to find out if they will be.
One
more thing is that almost all of the women in the core studies are white. Women of every racial group got breast
cancer, but only six African American women and five Asian American women are
in the Inamed reconstruction study.
Race is an important issue because African American women are more
likely to get autoimmune diseases than white women.
In
conclusion, not enough research has been done on large diverse samples of women
that proves that silicone breast implants are safe in the long term. Because of this, on behalf of the National
Council of Women's Organization and the ten million women NCWO represents, I
urge you to vote against the approval of silicone breast implants.
Thank
you.
CHAIRMAN
CHOTI: Good morning.
MS.
SILVERMAN: Good morning. My name is Virginia Silverman. This is my daughter Eve. She is six years old. I am from Laguna Niguel, California. Inamed paid for my flight here today. I am here today to talk about choice, a
woman's inherent right to choose what is right for her body.
In
September 2001, just days after September 11th, I was diagnosed with early‑stage
DCIS breast cancer. After educating
myself about the aggressive nature of my cancer, my treatment options,
recurrent statistics, and my potential for complete cure, I chose to have a
bilateral mastectomy. As a result of my
aggressive treatment choice, I was cured of the disease with no need for
chemotherapy, radiation, or tamoxifen.
To
expedite my recovery, I chose to initiate my breast reconstruction during the
initial cancer surgery. When I awoke
from the operation, the cancer had been excised and saline tissue expanders had
been inserted.
During
the 12 weeks following my mastectomy, saline was injected into my expanders
each week. As more and more saline was
injected, the saline implants proved to be extremely uncomfortable. The water was hard inside its
containers. And I experienced my
breasts as inflexible, immovable objects on my chest. With every movement of my body, I was acutely aware of the
foreign objects residing beneath my chin.
Finally,
my tissue extension phase was over. And
I received my permanent silicone implants.
I chose the Inamed silicone gel implants because I was confident, then
and now, after exhaustive research of their safety.
It
has been three and a half years since I chose to cure myself of breast cancer
and place silicone gel implants inside my body. Compared to the rigidity and discomfort of the saline implants,
my silicone implants are comfortable and pain‑free.
While
the saline implants were annoyingly inflexible and hard, my silicone implants
are pliable and comfortable, contouring to both my body and my clothing. They even move when I dance and exercise.
As
the Vice President of Marketing for Lindora, America's leading medical weight
management company, it is my responsibility to be an active advocate on behalf
of women's health issues.
I
stay abreast of the most current medical advancements leading to healthier,
happier lives for women everywhere.
After over a decade of diligent research showing virtually no health
issues with the product, I believe silicone gel implants should be available to
all women, whether they are breast cancer survivors or not.
In
conclusion, on behalf of myself, my six‑year‑old daughter Eve, who
is with me today, and all women who are choosing to enhance their lives through
breast reconstruction or enhancement, I urge you to approve the use of silicone
gel implants for wide consumer use.
We
have a right to decide what is right for our own bodies. I chose to live by electing my double
mastectomy. I chose to live well by
selecting silicone gel implants. I
choose to be here today to encourage you to give women here in America the
opportunity to choose for themselves which implant is right for their bodies.
Thank
you very much for your consideration and your time today.
CHAIRMAN
CHOTI: Thank you.
Yes? Next?
Good morning.
DR.
MAHARAJ: Good morning. I'm Dr. Susan Maharaj, and I am a professor
of chemistry. I have no conflict of
interest. Today I am presenting the
results of Maharaj 2004, Maharaj and Lykissa 2004, and Lykissa and Maharaj
2005.
Next
slide, please. Maharaj 2004. The results show that high levels of
platinum are present in silicone breast implant gel, shells, and in the
corresponding capsular tissue of women exposed to silicone breast
implants. The gel and shell platinum
values in this study are much higher than reported by manufacturers. Platinum tissue concentrations in women
exposed to silicone breast implants are higher than in tissue samples of women
not exposed to these devices. And, in
fact, the values do not overlap.
Next
slide, please. Maharaj and Lykissa 2004
and Lykissa and Maharaj 2005. Mean
platinum concentration in whole blood and urine samples of women exposed to
silicone breast implants was higher than in control subjects.
Mean
platinum concentration in whole blood and urine samples of children conceived
after their mothers were implanted was higher than in children conceived before
their mothers were implanted.
Next
slide, please. Mean platinum
concentration in hair, nails, and sweat samples of women exposed to silicone
breast implants and in children conceived after their mothers were implanted
were higher than that of the general population and higher than in children
conceived before their mothers were implanted.
Mean
platinum concentration in breast milk samples of women exposed to silicone
breast implants was much higher, about 100 times higher, than samples from
women not exposed to these devices.
Next
slide, please. Mean platinum oxidation
states in explanted silicone breast implants occur mainly in the +2, +4, and +6
valence states. This is a very
important point. Manufacturers are
claiming and FDA believes that platinum is in the zero valence state. Mean platinum oxidation state in whole blood
samples of controlled subjects was mainly in the zero oxidation state.
Next
slide, please. Mean platinum oxidation
states in whole blood and urine samples of exposed women were mainly in the +2,
+4, and +6 oxidation states. Mean
platinum oxidation state in whole blood samples of children conceived by
mothers after implantation and in a brain tissue sample of an exposed
individual were in the zero, +2, and +4 oxidation states.
Next
slide, please. In conclusion, my main
three points are as follows. Number
one, the platinum concentration in gel and shell material of silicone breast
implants is actually much higher than reported by manufacturers.
Number
two, the platinum concentration in many different types of samples is
consistently higher in women exposed to silicone breast implants than in non‑exposed
individuals and is higher in children conceived after implantation than in
children conceived prior to implantation.
And,
number three, silicone breast implants contain highly reactive forms of
platinum.
Thank
you very much.
CHAIRMAN
CHOTI: Thank you.
MS.
WOLF: Good morning. My name is Carolyn Wolf. I live in Virginia, and I came here at my
own expense. I have no conflicts of
interest.
In
1972, after subcutaneous mastectomies, I had reconstruction with the newest,
best construction, silicone implants, that were safe and would last my
lifetime.
There
were no problems in the beginning. By
the seventh year, burning, blister‑like growths started on my neck and
boil‑like growths on my forehead.
Sixteen years after, three days were spent in ICU because of severe
burning chest pains.
By
the 21st year, my family had noticed a change in personality. And I had noticed cognitive changes. By the 25th year, though a non‑smoker,
I was coughing up hard, greasy, gold‑colored plugs. X‑rays showed chronic obstructive
pulmonary disease.
A
military plastic surgeon checked me every year. I never connected my problems with the implants until my left
breast capsule collapsed 28 years after implantation. MRI showed both implants extensively ruptured. Shortly thereafter, a glob of silicone moved
from my breast into my armpit, leaving an elongated swelling in its path. There was excruciating pain.
In
April 2000, vision was lost in my left eye for 45 minutes. Pain continued in that eye until a long,
stringy glob came out of it several weeks later. Two similar strings were exuded from my left ear in the 30th
year.
Explantation
performed in 2000 showed the left implant measuring only four centimeters. The scar capsules surrounding the implants
contained chronic inflammation and foam cells containing silicone. Few women had implants as long as I.
I
have been diagnosed with silicosis, rheumatoid arthritis, connective tissue
disease, Raynaud's, and silicone‑induced MS‑like syndrome with
neuropathy of the extremities.
My
brain MRI shows more than 20 lesions.
My silicone level is .11, more than double what is normal. My platinum level is 20 times normal. Silicone continued to be exuded from my
nipples until simple mastectomies to remove painful calcified tissue was
performed six months ago.
National
Cancer Institute has conducted the only study of women implanted for more than
eight years. That found women are much
more likely to die of brain and lung cancers and suicide. If implants are so safe, make sure that
manufacturers prove that it is safe.
The
studies you will hear about tomorrow do not prove that. The women studied were not implanted for
more than ten years. You have no
control over the advice given or not given by plastic surgeons. What happened to me will eventually happen
to thousands of women with silicone implants.
And please do not inflict this on another generation.
CHAIRMAN
CHOTI: Thanks.
MS.
KEELING: My name is Marlene
Keeling. I am President and founding
Director of Chemically Associated Neurological Disorders, or CANDO. I have paid my own way here because of my
concern over toxic and hypersensitizing chemicals that I am convinced are
leaking or bleeding from implants into not only the bodies of women but, even
more worrisome, their children born after implantation.
I
was implanted with McGhan double lumen breast implants in 1978. I had my ruptured implants removed in 1994,
after I became convinced that my implants were causing my swollen lymph nodes,
hair loss, memory loss, overwhelming fatigue, peripheral and demyelinating
neuropathy. I was perfectly healthy
before I got implants, got sick, had my implants and scar capsule removed in
block and not replaced, got better.
When
tested for platinum six years after explantation, my urine was found to contain
36 parts per billion per liter of urine.
Platinum was found to leak from my implants. And platinum was also found in my hair, nails, sweat, and blood.
The
ionization or speciation of my platinum was +2 and +4. Dr. Joseph Bubinak, a board‑certified
hematologist and medical oncologist, testified before a breast implant advisory
board in 2002 regarding his experience with the chemotherapy agent cisplatin.
Dr.
Bubinak reported that he was astounded to learn that the catalyst used to
manufacture the silicone for breast implants was platinum chloride, a highly
reactive molecule and precursor to the chemotherapy agent cisplatin. He stated that some breast‑implanted
patients have the same systemic complaints and side effects as cisplatin‑treated
patients, including fatigue; hair loss; loss of short‑term memory; rash;
and other allergic reactions; respiratory system problems; and peripheral
neuropathy, which is sometimes disabling.
Dr.
Bubinak stated that the migration of reactive platinum alone could explain
capsule formation and tells the world that the chemicals in breast implants are
not inert.
Can
you go to C? Dr. Maharaj has presented
data from CANDO's research project number 1 here today. Based on this research, it was determined
that urine was the least invasive, best method to test for platinum levels in
the body.
CANDO's
research project number 2 has now tested the urine of over 50 breast‑implanted
women and their children born prior to and after implantation. I have copies of this raw data, which I can
give to the panel today.
Previously
in a written submission, I gave the panel a copy of the CDC's platinum urine
study in the general U.S. population of over 1,000 people. And not one of them had over the level of
detection of 0.04 parts per billion.
To
quickly recap, the results of the raw data presented today, one child born
after implantation tested over 300 parts per billion. One woman tested over 200 parts per billion 11 years after
explantation. And nine women and one
child tested over 100 parts per billion.
The
panel was also given a copy of Dow‑Corning's 1996 letter notifying the
EPA of substantial risk to their platinum catalyst used in breast
implants. Ionized platinum is on the
list as being a suspected neurotoxicant and immunotoxicant.
Mentor's
most recent FDA‑approved product insert makes the following statement,
"Toxicity studies are currently in progress by various research
facilities, universities, government agencies, the medical community, and the
medical device industry. Some of these
studies are conducted in animal models to determine potential immunotoxicity
and autoimmune issues related to silicone materials. There is the potential that in the animal models being studied,
immunotoxicity may result."
I
submit it is not safe enough for the FDA to simply say it is not known if a
small amount of silicone may pass from the silicone shell of an implant into
breast milk. If this occurs, it is not
known what effect it may have on the nursing infant. We must protect our future generation, who cannot make a choice.
Thank
you.
CHAIRMAN
CHOTI: Yes? Good morning.
DR.
MAO: Good morning. My name is Jeremy Mao. I am Associate Professor of Bioengineering
and Cell Biology at University of Illinois.
I come here today with no financial ties to either the sponsor or any of
their competitors. My testimony today
will be related to mechanical testing of silicone breast implants.
I
have reviewed the scientific and regulatory literature extensively on
mechanical testing of silicone breast implants. After review, it seems that there is a shortage of data,
mechanical testing of implants in simulated in vivo environment.
The
in vivo environment surrounding silicone breast implants is complex and
consists of fibrous capsules, many cytokines, protolytic enzymes. The local chemical and physical environment,
such as pH and temperature, may also affect the outcome of mechanical testing.
There
is experimental evidence that the in vivo environment weakens silicone gel
breast implant shells over time.
Several articles published in Plastic and Reconstructive Surgery and
other journals have demonstrated the need for performing mechanical testing in
simulated in vivo environment.
Silicone
breast implants rupture for a variety of reasons. The complexity of tissue‑borne mechanical stresses on
implants is a result of tension, compression, and shear stresses. In most previous mechanical testing studies,
only uniaxial mechanical forces are applied.
This represents only one of the multiple dimensions of mechanical
stresses in vivo.
Multidimensional
forces may be used to simulate mechanical testing of breast implants to
adequately simulate the conditions in vivo in the patient's body.
ASTM
International has several guidelines for testing silicone breast implants, such
as tensile strength, ultimate elongation, and fatigue life. However, in 1989, Plastic Surgery
Subcommittee members stated that the tensile and tear strength measurements are
not particularly relevant to the clinical circumstances under which implants
rupture.
In
addition, there is a need to examine whether there is a correlation between MRI
findings of rupture or potential rupture with mechanical testing data. A recent article in the European Journal of
Radiology reports correlation between MRI findings of silicone breast implant
rupture and clinical examination at the time of implant removal. However, it is known in the literature if
there is a correlation between MRI findings and implant rupture and mechanical
testing of the implant prior to and after implantation.
Mechanical
testing prior to implantation could be useful reviewing what type of implants
are more susceptible to MRI‑detectable ruptures.
Thank
you.
CHAIRMAN
CHOTI: Yes? Good morning.
DR.
MELMED: Good morning. I'm Edward Melmed. I have no conflict of interest.
I am a plastic surgeon who has done breast implants since the day they
were introduced. I did my first year of
residency in 1963, when Cronin first introduced silicone implants. So I have seen the evolution through the
Cronin implant; the Jenny (phonetic) inflatable, which was a balloon through to
the silicone pads; the Dacron patches; Meme implants, et cetera.
I
wrote extensively about this in the Plastic and Reconstructive Journal in the
'90s. But from 1992, I had a complete
change‑around. I started seeing
the devastation and complications from breast implants. And since 1992, I have explanted over 800
women with breast implants. I wrote
about this in Plastic and Reconstructive Surgery in 1998.
My
statistics that I wrote in 1998 showed a rupture rate at 10 years of
approximately 50 percent, a rupture rate at 15 years of 70 percent, and a
rupture rate at 20 years of 94 percent.
My current figures show no deviation from this. It's a time‑dose‑related
phenomenon. Research that shows two,
three, or four years' duration, my statistics show the same. It shows a four percent rupture rate.
The
problems become manifest the longer the implants are in. The implants will rupture and just
disintegrate. And sometimes no wall of
the implant can be found.
I
have brought some short clips that I'd like to just show in the background of
what implants really look like when you get into the 10‑15‑year
rate of removal. The silicone will
simply well out with no visible evidence of any wall.
Now,
if we take the statistics that are currently available, approximately 330,000
women received breast implants in ‑‑ at least 2004. If we extrapolate that figure ‑‑
sorry. Let me backtrack and say that if
we accept that no medical device is safe ‑‑ and I think we must say
that ‑‑ then just assuming there's one percent failure rate, at 10
years, you're going to have 33,000 women with problems, which if it becomes 3
percent is 100,000 women.
Now,
no batch can be identified of what implants disintegrate. So we're left with this uncertainty of the
future of these women. So a girl of 16
who you are going to allow this device in is very different from the 70‑year‑old
who has a hip prosthesis that might fail, a woman who is going to be left with
an inevitability of having four or five operations in their lifetime.
Lastly,
how do you recall implants? If I buy a
new Ford and it has a brake problem, the National Highway Traffic Safety will
report it if there was more than one percent failure rate. Here we've got 17 percent failure rate. How do we recall them?
Thank
you very much.
CHAIRMAN
CHOTI: Sir, we have a question
here. Yes?
MEMBER
LI: This is Steve Li, Dr. Melmed. Just one quick question. Your rupture rates, was that your own
personal experience of your own patients?
DR.
MELMED: That's our own personal
experience in practice.
MEMBER
LI: And roughly how many patients was
that?
DR.
MELMED: That was over 500 patients.
MEMBER
LI: And just over what calendar period?
DR.
MELMED: From 1992 until 2004.
MEMBER
LI: Thank you.
CHAIRMAN
CHOTI: Yes? Good morning.
DR.
ZONES: Good morning. I'm Dr. Jane Zones, a medical sociologist
here representing Breast Cancer Action as a member of its board of directors.
Breast
Cancer Action is a national grassroots membership‑based education and
advocacy organization that works to make the changes necessary to end the
breast cancer epidemic. BCA has a
corporate donations policy that forbids us from accepting donations from any
entity that might present a conflict of interest. This includes not only all health industries but organizations
whose products or manufacturing processes may contribute to cancer incidents
generally.
We
have no financial interest in the outcomes of these hearings.
Breast
Cancer Action's major concern is the continued lack of data to assure long‑term
safety and the need for specific guidance for women seeking reconstruction
after mastectomy that would allow making an informed decision about the
silicone breast implants. In
particular, we are disturbed by the data supplied by the applicants on short‑term
complications and resurgeries that are particularly prevalent in women
undergoing reconstruction after mastectomy.
We
are grateful for the care which the FDA staff analyzed the data submitted by
the applicants and agree with FDA's analysis that the assumptions employed in
industry's projections improperly minimize the risk of rupture in the future.
We
have many breast cancer‑related concerns with silicone breast
implants. Today, however, I would like
to address a topic not specific to breast cancer, which is post‑marketing
surveillance.
At
the October 2003 meeting of this committee, Inamed struck a deal that promised
ongoing follow‑up of women in their studies in return for a conditional
approval by the panel. This appeared to
have been negotiated with at least some on the panel behind closed doors during
the night before the vote. By early in
the morning on the last day of that meeting, dozens of copies of the proposed
agreement had been duplicated and were handed out to meeting participants.
Since
the FDA Modernization Act authorized FDA to conduct post‑marketing
surveillance of drugs in 1997, hundreds of new drug reviews have required Phase
IV post‑marketing clinical studies as conditions of their approval.
In
their most recent report to Congress, the FDA indicates that over two‑thirds
of new drug approvals with open post‑marketing commitments had not yet
initiated required Phase IV studies.
The
situation for medical devices is even less developed. In June 2002, FDA announced plans to require manufacturers of
some devices to conduct post‑marketing surveillance for up to three
years. Breast implants are covered by
this rule because the category includes medical devices implanted for more than
a year.
However,
there is no reason to expect device manufacturers to be any more compliant than
pharmaceutical companies in their pursuit of post‑market approval
data. In fact, an article in the Wall
Street Journal less than two weeks ago quoted an internal report by FDA
scientists, saying that the CDRH had only limited procedures for monitoring
manufacturers' progress and results.
Of
45 devices conditionally approved between '98 and 2000, nearly two‑thirds
included no information about post‑marketing studies in manufacturers'
annual reports to the FDA. Final
results on over half of studies that were known to be due had not been
submitted.
FDA
has little recourse where manufacturers either fail to meet post‑marketing
commitments or find evidence of greater risk except to pull the product from
the market. This has never happened
with devices nor, as far as I know, with drugs.
The
dramatic removals we have witnessed in recent years have usually involved
whistle‑blowers, leaked documents, journalistic exposes, or unexpected
findings from post‑market studies designed to broaden indications for use
of the product.
Inamed
and Mentor have proposed up to ten years of total follow‑up of the women
in their studies, but the medical device regulation has an upper limit of three
years, which, if effected, would preclude prospective analysis of the effects
of aging of the implants, which are thought to rupture at increasing rates.
We
urge the panel to act on the data that is now before you and not on that which
may be promised in the years ahead. The
manufacturers know that it is unlikely that you would ever be called to review
post‑market surveillance data in the future and that the consequences for
less than quality follow‑up or for findings of greater risk are minimal.
Women
who are at risk for breast cancer or who currently are living with the disease
are depending upon you to hold these devices to a high standard.
CHAIRMAN
CHOTI: Thank you.
Next
speaker, please.
MS.
PAM DOWD: Hello. My name is Pam Dowd, and I have been asked
to speak on behalf of Cristy Warschaw, founder of Women in Health, one of the
largest support groups in southern California for silicone breast implant
women. Neither she nor I have any
affiliation with Inamed or Mentor.
Neither of us have received monies from either company for this
testimony.
"I,
Cristy Warschaw, have had both Inamed and Mentor post‑1990 silicone
breast implants. I am unable to attend
this hearing because of my continued health problems associated with these
implants.
"My
history is very simple. No health
problems until November 1989, when at age 28 I underwent a mastectomy with
reconstruction with silicone breast implants.
"I
had a family history of breast cancer and calcified fibrocystic disease. I became ill as soon as the implants were
placed. I had to stop working as a
medical administrator and stop my Master's degree program at UCLA.
"I
have been on disability for most of the last 16 years. I have had seven surgeries, all associated
with the implants. As of today, at the
age of 43, I have undergone total mastectomy with no further reconstruction
because I am not a candidate for TRAM flap or any other reconstructive surgery.
"It
has been discovered that I am one of a few people allergic to silicone. If I even ingest milk, I can have an
anaphylactic reaction as silicone is used as a defoaming agent in processing. I cannot place any silicous, silicones,
dimethicones, or any cones on my body because I will break out in a rash.
"IV
needles are coated with silicone, and I have not been able to keep one in me
for more than one day because of the silicone reacting and inflaming the IV
site.
"Having
been a support group leader for 12 years and having had both manufacturers'
implants, I have done a lot of investigation on both companies. My number one concern is the FDA 483
inspections. Inamed is manufacturing
its SBIs in Costa Rica. By what means
is the FDA inspecting this manufacturing plant?
"Mentor's
manufacturing facilities in Texas have failed viscosity, dipping, and humidity
control over and over again. Also,
medical device reporting has also proven to be a problem as well.
"If
the FDA is taking Inamed's chemistry and mechanical testing from only Inamed's
say, then this is a complete failure on behalf of the FDA. It is also jeopardizing every woman
receiving an SBI.
"Neither
company has ever been able to assure shell thickness during the dipping process
due to inability to control humidity.
So they cannot predict clinical outcomes, as requested by the FDA,
because each lot will produce a different result.
"As
a health care professional who has kept clinical data for FDA experimentation
and clinical trials, I have great anxiety in allowing silicone breast implants
to be placed back on the market.
"Also,
having been a support group leader and seeing women affected by SBIs, I know
how people fall out of the studies.
Women will not see a reason to follow up in‑house with a plastic
surgeon at the recommended intervals.
"There
is no way a physician can detect a silent rupture. MRIs cost thousands of dollars.
The study is already set up to fail.
Women move. Women with SBIs are being
treated for cancer. Therefore, there is
a higher mortality rate for these women.
"No
guards are set in place to retrieve post‑mortem implants for study. There is a strong possibility these women
can lose health insurance and will not return for follow‑up appointments.
"Women
will have a problem and not return to the same surgeon. They may very well go to a surgeon who is
not part of the study. What happens to
those implants?
"Women
do not relate their fatigue to implants and are seen by their personal M.D.s
for this and may not relate these to silicone breast implants.
"I
have had four different surgeons and to this day and am in possession of four
of my five implants. The silent
contained rupture was not noticed on MRI two days before I had surgery. Four years after this rupture, I had 15
granulomas relieved from my chest wall by yet another surgeon.
"There
has never been an FDA PRP report filed on me or MDR report on my rupture or
fungus‑infected implants. I fell
through all the loops. And as a support
group leader knowing about breast implants, how many of these women will fall
through the loops as well? Women with
breast cancer are too busy worrying about their lives to think about SBIs. They just want to be whole again.
"I
could go on and criticize each part of the draft guidance for industry and FDA
staff saline, silicone gel, and alternative breast implants, but that would
take up more time than I have. It is my
opinion that neither company has met the FDA guidelines to demonstrate a
reasonable assurance of the safety and effectiveness of SBIs. Therefore, they should deny approval.
"After
ten years of trying" ‑‑
CHAIRMAN
CHOTI: If you could sum up, please?
MS.
PAM DOWD: Yes. I've just got this one sentence.
"After
ten years of trying, yet just not making it, SBIs should be removed from the
market altogether."
MS.
SMITH‑MILES: Good morning. My name is Rebecca Smith‑Miles, or
Becky. I am from northern
Michigan. I am a registered nurse. My husband is a radiologist. I have no conflicts of interest.
I
had silicone implants put in over 15 years ago. Within two years, I developed capsular contracture and
experienced intense pain. My plan to be
more beautiful was ironic in that I was uglier by the day. I had larger breasts, but they were hard,
painful, and ugly. I was ashamed for
even my husband to see them.
Within
seven years of getting the implants, I was diagnosed with an atypical
neurological disease. Eight years after
being implanted, I had my implants and scar capsules removed. They had ruptured. And the plastic surgeon attempted to retrieve all of the leaked
silicone, but he was unsuccessful.
If
I had been included in the three‑year and four‑year studies at that
time, only capsular contracture and pain would have been picked up, not the
rupture and not the systemic problems.
I
have gone from being a very athletic and active person to being physically
inactive and at times bedridden. I
worked daily prior to getting implants.
Now I'm on disability. And
sometimes I'm even unable to perform my daily household tasks, simple tasks.
I
have severe overwhelming fatigue, joint and muscle aches, pain, dry, scratchy
eyes, skin rashes, numbness in my calves and toes, hair loss, night sweats, and
daily headaches. I am easily confused
and have a constant fog in my head.
My
skin develops rashes and reacts to previously normal substances. I have blister‑like eruptions in my
fingers that are intensely painful. And
along with the pain comes burning and itching and total intolerance to any
pressure. I can't use that finger. I scratched it and scratched it until the
top came off. And then I felt with my
tongue a tiny sliver of crystal. When I
got that crystal out, it healed immediately.
I
fear that I have silicone crystals running throughout my body, and I wonder
what kind of damage it has done to my internal organs. I had silicone leakage in my chest, axillary
lymph nodes down my arms.
My
last surgery a year ago removed silicone after an ultrasound located it in my
chest and breasts. I had a lemon‑sized
portion of my right breast tissue removed as a result of the leaking silicone
from the rupture over ten years ago.
The surgery has made that right breast noticeably smaller, but it's
worth it.
My
life since getting implants has changed completely. My social and family lives have suffered. I can no longer be a normal wife, mother, or
grandmother. Even so, I'm lucky because
my husband is a physician, and we are not financially devastated by my disability.
I
beg you, as you make this very important decision, think not only of my
experience but also of the lives of other women, your friends, your relatives,
who may end up like me. Silicone
breasts are not worth the known risks, let alone the unknown long‑term
risks.
Thank
you. Any questions?
CHAIRMAN
CHOTI: Thank you very much. Good morning.
MS.
DALY: Good morning, ladies and
gentlemen. My name is Anna Daly, and
I'm from Nashville, Tennessee. I was
asked to come and speak to you today by my plastic surgeon, Dr. Melinda Haws,
of the Plastic Surgery Center of Nashville, and the Inamed Corporation, who
provided my transportation and lodging.
On
December 30th of 2003, I had my very first mammogram. On January 26th of 2004, I was diagnosed with ductal carcinoma,
breast cancer, on my left side. Though
the cancer was still fairly small and had not yet spread, it was labeled as
high‑grade and aggressive. And I
was not yet 40 years old, with a 2‑year‑old and a 4‑year‑old
at home.
After
speaking with my family and the doctors involved, we decided the best option
would be to undergo a bilateral mastectomy with immediate reconstruction using
tissue expanders, which I did on February 13th. The choice was made because of the nature of the cancer, the
probability of it recurring on the opposite side, and the symmetry that would
be provided by doing both sides at once.
During
the next five months, we discussed and researched my implant options: saline versus silicone, smooth, textured,
and size. The tissue expanders that I
received were saline‑filled. And
my experience with them was not a pleasant one. I did not like the fact that I could hear the liquid sloshing in
my chest, nor feel the saline moving from side to side as I walked, caused
several cases of severe motion sickness that I did not want to repeat.
Appearance
was also considered. I didn't like the
way the saline‑filled implants have a tendency to ripple. And the profile of the implants did not
appeal to me. So I made my decision.
After
signing a waiver regarding the possible side effects and enrolling in a
research study to be conducted over the next five years, I had my tissue
expanders removed. And I chose to have
silicone‑filled implants on July 1st of last year.
I
like the projection of my breasts that the silicone‑filled implants
provide because it is very natural. The
feel is also very natural to the touch.
And they are as close to the feel of my own breasts that I could have
imagined.
After
going through the invasive nature, trauma, and emotional upheaval of a
mastectomy, appearing and feeling normal become very important to you. Important also is the fact that I have a
choice in the type of implants that is to be placed in my body.
So
many choices are already made for you when you are faced with a cancer
diagnosis. Knowing that I could help
choose the way I would look coming out of this was very empowering and very
uplifting.
My
request of you is to clear the way for silicone implants to be a choice for all
women, reconstruction or augmentation, research study or not. We all deserve to feel beautiful and, if not
beautiful, at least normal.
CHAIRMAN
CHOTI: Good morning.
MS.
ANTOLICK: Good morning, ladies and
gentlemen. My name is Karen
Antolick. And I live in Columbus,
Mississippi. I have no conflicts of
interest.
My
desire for implants began at the age of 15.
And then at the age of 22, I took my savings along with a small loan and
had silicone breast implants placed.
I
was told by my plastic surgeon that sometimes implants could hard and have to
be replaced but that if I massaged my breasts as instructed, that this was most
likely not going to happen. I was told
that breast implants were a lifetime investment and safe. I also did not receive any literature
outlining the potential risk.
I
thought that my life could only improve with implants. And after my surgery, I felt implants were
the best thing that had ever happened to me.
Within
the first year, however, I began having serious medical problems. Over the years, I was in and out of doctors'
offices with various symptoms: chronic
fatigue; memory loss; migraines; chronic pain; hearing loss; burning in my
chest; and numbness in my lips, hands, and feet. I did not know, nor did the doctors, that most of these symptoms
are autoimmune symptoms and common with breast implant patients.
The
pain and burning in my chest along with nipple discharge became so severe that
I went to a plastic surgeon to have the implants removed. Once removed, my doctor told me that both
implants were ruptured, capsulated, and had been leaking for many years.
During
the surgery, she removed lymph nodes because they had become contaminated with
silicone. This was very surprising to
me because each year my mammogram showed that my implants were intact.
I
am not unusual. I now know that FDA
study found that most augmentation patients had at least one broken silicone
implant within ten years. And silicone
migrates outside of the breast capsule for 21 percent of women with implants.
I
was young and naive when I received implants.
I didn't have the foresight to see that my health is much more important
than my breast size. Instead of
providing me with self‑esteem, like I thought, they provided me with a
life of pain and dependency.
Now,
23 years later, I can no longer work as I used to. I had to move closer to my parents so that they could help care
for my children. Probably the most
difficult change I have had to come to terms with is not being able to care for
and enjoy my children the way that a mother should.
Please
make sure that young girls who are considering implants will not have to
sacrifice their health for a certain body type like I did. Thank you for your time and consideration.
DR.
TEBBETTS: Good morning. Dr. Choti, members of the panel, I am Dr.
John Tebbetts. I am a board‑certified
plastic surgeon. And my testimony this
morning is based on 26 years of clinical experience performing breast
augmentation; 17 years of experience designing breast implants; and my peer‑reviewed
publications, which I have provided members of the panel.
I
have a conflict of interest but not with the devices here today. I have designed devices for Inamed
Corporation, received compensation as a consultant. None of my devices are under consideration. And I am here today to speak to you about an
issue that really applies more to all devices but has concerned me for some
time.
For
the past 15 years, through 3 PMAs for totally different devices, surgeons,
plastic surgery organizations, and manufacturers have not improved the 15 to 20
percent 3‑year reoperation rates for primary breast augmentation. I believe that one of the main reasons for
that is that our educational methods are not sound.
Although
we have provided information and previous panels have made recommendations
about specific information to be provided, we are not teaching patients and
surgeons how to make decisions. We are
not testing to ensure that the information has been delivered. And we are not providing incentives to
assure implementation of best practices that we know by peer‑reviewed
results have been proven.
The
bias characteristics affect outcomes in only a percentage of cases while
patient and surgeon decisions impact outcomes in every case, regardless of the
device and often far more than the device itself.
As
we listen to saga after saga of compromised outcomes, we should be asking
ourselves, was it the device or was it the decision‑making process of the
patient and the surgeon. Could the saga
have been avoided or at least terminated early by simply applying endpoints,
removing and not replacing the implants?
The
best indicators of quality of surgery are the patient experience and
reoperation rates. Today, over 80
percent of augmentation patients can be out to dinner the evening of surgery
without bandages, drains, pain pumps, or narcotic pain medications.
And
96 percent of those patients can return to full normal activity the next day
with a 3 percent 7‑year reoperation rate. Most patients have no idea that this level of outcome is
routinely possible and even being delivered by surgeons less than ten years in
practices.
The
processes and practices that generate these peer‑reviewed results can
directly impact outcomes and reoperation rates but only if they are transferred
through optimal education.
Improving
patient outcomes requires accountability from those who make decisions and from
those who provide education and who want to provide certification.
I
hope that, as you consider these devices and other devices, you will make
strong recommendations in that regard.
There are good solutions. Time
does not allow me to go into them today.
Thank
you for your time and the opportunity to address the panel.
CHAIRMAN
CHOTI: Thank you.
Good
morning.
DR.
FRAGEN: Good morning. I approached Inamed and Mentor and
volunteered to come here today to speak to the panel. I am a member of their institutional review boards. And Inamed did provide for my
transportation. I am kind of a gray‑haired
doc. And I thought it would be
interesting to give you my perspective.
My
name is Ronald Fragen. I am a physician
and surgeon who has been performing breast implant surgery for 30 years. I practice in Palm Springs, California. I have traveled across the country because I
believe women are able to evaluate the risks of breast implant surgery and make
their own decisions without restriction.
To my knowledge, no other country restricts the use of silicone gel
implants and 60 countries have approved their use.
I
was licensed to practice medicine in 1964 and began practicing medicine in
California in 1971. I have performed
breast augmentation surgery for 30 years.
Just
so you know me, I was an Assistant Professor at the University of California
Medical School at Irvine for 20 years.
I am the past President of American Society of Cosmetic Breast Surgery,
past President of American Society of Liposuction Surgery, past President of
California Academy of Cosmetic Surgery, and a member of the board of directors
of both the American Academy of Cosmetic Surgery and the American Board of
Cosmetic Surgery. I have practiced
exclusively cosmetic surgery for 20 years.
I
have seen nearly every breast implant ever used. The current silicone breast implants have been used in my
practice since the mid 1980s, when they were first introduced. I have patients who have had these implants
in for 20 years.
With
the old implants, 20 to 25 percent of our breast surgeries every year were
revised problems, usually capsule contracture or rupture. In the last 20 years, I cannot find 15
patients who have needed revision surgery using the new gel implants.
I
have done thousands of breast implants.
The new implants have a thicker shell and a coherent gel that doesn't
run. The old implants had a thin shell,
more fragile, a gel that flowed like sticky molasses. Since using the new implants, I have seen only one shell
split. And that gel did not leak. It behaved like cut Jell‑O. There was no leakage.
Do
not mix the results from old implants and the new thick‑shelled implants
with coherent gel. These new implants
are safe. By comparison, aspirin is not
safe. Skateboards, skiing, motorcycles,
alcohol, tobacco, and exhaust from automobiles I think are far more hazardous.
Women
have many breast deformities:
congenital; small; malformed breasts; breasts that change after cancer
surgery; and the largest group, those whose breasts have become deflated skin
sacs after pregnancy.
Most
of these patients I see fall in the latter category. They cannot wear clothes they desire and often lose self‑esteem. They desire to regain their shape. We allow women who have congenitally
deformed breasts and women who are cancer survivors to regain their shape using
silicone gel implants. These women and
their surgeons pick the best implant to fit their anatomy without restriction
from the FDA.
Implants
are safe for these people. Why do we
trivialize post‑pregnancy breast deformity and not allow these women and
their surgeons free access to the best implant for their particular
anatomy? We should.
These
implants are safe. Saline implants are
stiffer. They ripple. And they more often give a balloon‑like
shape. However, they are easier to
implant. It's an easier operation for
the surgeon than a silicone gel implant is.
A silicone gel implant is a better choice for the patient in many
instances, however.
CHAIRMAN
CHOTI: If you could wind up, please?
DR.
FRAGEN: Yes. These implants are a new and better machine and should not be
compared to the old implants. This is
really a woman's issue. The surgeons
have no secondary gain to use silicone implants.
I
just want to tell you that one of my reasons for going into medicine was an
aunt who started practicing medicine right after World War I before the
Nineteenth Amendment to the Constitution was enacted. That's the women's right to vote. I'm sure she would not have ‑‑
CHAIRMAN
CHOTI: Sorry.
Next
speaker? Good morning.
DR.
KASPER: Good morning. My name is Anne Kasper. I have worked in women's health for 30
years. I have been a breast cancer
counselor for four years in Bethesda, Maryland. I am also the Breast Cancer Counselor for Mobile Medical Care,
which serves the uninsured, low‑income, and homeless of Montgomery
County, Maryland. I am the Senior
Editor of Breast Cancer: Society Shapes
and Epidemic, a book published in 2000.
The
women I counsel who have faced breast cancer have one primary concern. They want to survive this disease and live
out their lives for as long and as healthy as possible. Women want to be able to trust that the
treatments and recommendations given them by health professionals, science,
researchers, and drug and device manufacturers will halt the progress of the
disease and promote their health and well‑being. Few women want to take any unnecessary risks
with their health once they have faced a diagnosis of breast cancer and endured
its treatment.
For
many women who have undergone the loss of a breast looking and feeling normal
and comfortable without further health risks involves no more than a good
mastectomy bra and well‑fitted prosthesis.
Many
women who are offered breast reconstruction refuse it because they don't want
to undergo further surgery, anesthesia, risk of infection, and recovery. They are also concerned that a breast
implant will obscure finding a breast cancer recurrence or that the implant
will rupture and further surgery will be needed.
There
are also many more options than there used to be for breast cancer patients who
want to keep their breasts. More than
three out of four of the women who are newly diagnosed with breast cancer are
eligible for lumpectomy and, therefore, won't need reconstruction.
The
number of women who need a mastectomy, instead of a lumpectomy, is much smaller
than it used to be. In addition, women
who undergo mastectomies have other alternatives to silicone breast implants. Saline breast implants have a lower
complication rate and do not cause, as far as we know, the serious problems if
they leak as to silicone implants.
Many
women tell me that they don't want silicone breast implants because they have
never been proven safe specifically for women with breast cancer. Having endured cancer in their bodies, women
tell me that the last thing they want to do is willingly introduce a foreign
substance that has not been proven safe over the long term, will rupture in
time, will leak silicone into the body, will interfere with mammography, and
may cause additional health problems as well as repeated surgeries.
Implant
makers tell us that women need silicone gel implants for their emotional well‑being. Today you're hearing from patients who say
they want implants to help them feel better about themselves and that it
improves their quality of life.
However, we know that there are no studies to support that claim.
A
study by Dr. Julia Roland and Dr. Patricia Ganz and colleagues compared the
quality of life of women who underwent lumpectomy, women who underwent
mastectomy, and women who had mastectomy with reconstruction. They found no difference, no difference, in
quality of life between the three groups of women.
There
were some differences in certain aspects of their lives, however, but the
reconstruction patients were not necessarily the happiest ones. As I consider the needs of the cancer
patients I work with, the lack of long‑term safety data and the lack of
evidence that breast implants improve women's quality of life, I don't see a
reason to approve silicone gel breast implants.
I
urge the FDA to once again deny approval to silicone breast implants. If the companies finally develop a safer
implant in the future, the FDA can then reconsider.
Thank
you.
CHAIRMAN
CHOTI: Thank you.
Good
morning.
MS.
BEAGLE: Good morning. My name is Kitty Beagle. And I am here today speaking on behalf of
Anna Carpenter, who was, unfortunately, unable to attend the meetings.
"My
name is Anna Carpenter. And I am a
member of the Younger Women's Task Force.
The task force is a project of the National Council of Women's
Organization, which represents over 200 women's groups across the nation. As a young woman in the age of cosmetic
surgery, reality shows, like 'The Swan,' 'Extreme Makeover,' and 'I Want a
Famous Face,' I'm here to talk about what kind of risk these devices pose to
women in my generation.
"Our
parent organization is the sponsor" ‑‑
CHAIRMAN
CHOTI: Excuse me. One moment.
I wonder if the group who is walking back there, if you could just hold
off on that so we can hear the discussion.
Okay? The point is for the
speaker to speak at the podium if that would be all right. Thank you.
I'm
sorry. Continue.
MS.
BEAGLE: Thank you.
"Our
parent organization is the sponsor of the Extreme Measures Tour, a body image
campaign which is traveling the campuses across the nation featuring young
women telling their peers about their personal experiences with failed breast
implants. The response has been
astounding.
"On
one Texas college campus, the school's volleyball coach asked that the speakers
would visit with the local girls' high school team because all of the players
were insistent that they would receive breast implants on their 16th birthday.
"At
a New Jersey campus, audience members told story after story of young women
receiving complication‑laden breast implants before rushing sororities.
"The
extreme measures campaign Web site has received e‑mails from women on
campuses across the country asking that the tour visit their school. Why is this happening? Why are women on college campuses so eager
to hear about their peers' experiences with breast implants?
"Look
at the numbers. The American Society of
Plastic Surgeons recently reported that this past year, 3,962 augmentation
procedures were performed on women 18 years and younger, a shocking increase
from the roughly 400 procedures done on the same age group in 1994. Three thousand, nine hundred, sixty‑two
means approximately ten teenagers receive breast implants every day.
"According
to manufacturers' own data, 21 percent of these teens will require reoperation
within 3 years. That means that every
day, 2 of those teens going under the knife will be back on the operating table
within 36 months. That is not including
the staggering numbers of young women who will experience what is termed 'local
complications.'
"Surgery
is surgery. And it carries inherent
risks, no matter how minor the procedure is billed to be. Manufacturers state that breast implants
will need to be replaced every ten years.
"A young woman who receives breast
implants on her 18th birthday and lives to be 88 will need at least 7 sets of
implants in her lifetime, each time paying out of pocket for the removal of the
old sets and implantation of the new sets, because health insurance rarely
covers the cost of problems related to breast implants.
"Even
more troubling, many insurance companies will not enroll a woman with
implants. Few teens can grasp the
significance of what having health insurance means, let alone how not having it
could create extreme financial hardships in the future.
"As
a young woman, it is also hard to understand the importance of early detection
and mammography. Mammography misses 55
percent of the cancers in women who have implants. Will young women take this into account when considering
implants?
"Although
some cosmetic surgeon groups may not endorse silicone implants for use in
teens, I will remind you that the FDA does not have a mechanism to police the
sale of implants once restrictions are lifted.
I will remind you that Dr." ‑‑
CHAIRMAN
CHOTI: If you could wind up, please?
MS.
BEAGLE: Thank you.
CHAIRMAN
CHOTI: Sorry. Thank you. I apologize,
but we really need to try to stay on time.
Thank you.
Next? Good morning.
MS.
HEIDE: Thank you. Good morning. And thank you for the opportunity to speak here today.
My
name is Terry Heide. I am 51 years old,
married with no children. And I work as
the congressional liaison for the Department of the Army's contracts for the
reconstruction of Iraq.
I
was diagnosed with breast cancer in January '03. I had bilateral mastectomies in July '03 and reconstruction with
tissue expanders. I received my
permanent silicone implants in October '03 and have had no health problems
since.
I
also have no financial interest in Inamed, Mentor, or any other medical
company. And neither Inamed nor Mentor
nor anyone else is paying any expenses associated with my appearance here
today. Those are the facts about me,
but it is not who I am.
Who
I am is an intelligent, educated, and compassionate woman who knows her own
mind. Who I am is a woman who has
always made decisions, tough decisions, using the best information
available. Who I am is no different
than any other woman who has faced challenges and triumphs, loss and recovery.
Like
many other women, unfortunately, I had breast cancer. But, unlike thousands of other women who are diagnosed every
year, I did not require chemo or radiation.
I had my first surgical biopsy when I was 19 years old. So I have been closely monitored my whole
adult life.
I
was lucky my cancer was caught early and was easily treated. I was also lucky to have my choice of
implants. And never once did I consider
any other option other than silicone.
I
am well‑read regarding the science on silicone implants. And, again, being in the business that I am,
I am also well‑aware of the politics of breast implants. This here today is about politics, not
science.
Silicone
is a common material in a wide variety of implantable medical devices. And there are even acceptable medical uses
of liquid silicone. And none of these
other products or uses have been restricted or banned. It is only breast implants.
There
are also many implantable medical devices that fail at a rate equal to or
greater than the rate at which silicone implants might fail. And none of those other products have been
restricted or banned. It is only breast
implants.
The
reason I believe is because silicone breast implants are a woman's health
issue. And there is an assumption at
work here that women are incapable of making sound and rational decisions about
their health or their bodies, that somehow we need to be protected from
ourselves simply because we are women.
Silicone
is the closest to real breasts. It
looks the closest to real breasts and feels the closest to real breasts. But it is not right for everyone. The decision to have a mastectomy or
reconstruction or augmentation or saline or silicone implants is an individual
decision and one that can only be made in consultation with a woman's
doctor. But this here is not about
science.
Yes,
implants fail and planes crash and people get cancer. There is no guarantee that life will be as we wish it to be. We all make decisions every day about how we
live our lives that involves risks.
There are hundreds of products out there made to make people feel more
whole, such as hip replacements and titanium rods that go into people's
back. And all of these things ‑‑
CHAIRMAN
CHOTI: If you could sum up, please, for
us? Thank you.
MS.
HEIDE: Thank you.
CHAIRMAN
CHOTI: Just sum up for us, if you
would, please?
MS.
HEIDE: Oh, yes. My concern is that I wish there was no
breast cancer. I wish we weren't here
today. I wish that everybody had the
body and the breasts and the health that they wish for. But, unfortunately, that isn't how life
works.
And
I am extremely concerned that the FDA would make women come here and talk about
this most private of things.
CHAIRMAN
CHOTI: Thank you. I'm sorry.
Next
speaker? Good morning.
MR.
MILLER: My name is Steve Miller. I have no conflict of interest. My wife is here today. And she will be sharing her story about how
silicone implants she received for correction of a congenital defect have
harmed her.
I
am reading this testimony on behalf of another man whose wife has also suffered
greatly due to silicone implants. I am
here to read the testimony of T. Wade Clegg of Panama City, Florida who could
not be here with us today. He has no conflict
of interest.
"My
family life has been severely affected by my wife's disastrous experience with
silicone gel breast implants. That is
why I wish to share my thoughts with the Advisory Panel.
"I
believe that silicone gel is one of the most insidious and invasive products
ever allowed in the public marketplace.
Silicone can migrate to distant places within the body, such as the
liver, thyroid, under the arms, into the arms, and across the chest. Such was my wife's experience.
"For
years, her neck would swell and diminish, blocking her breathing. Her thyroid was removed, and the pathology
report said it was Sjogren's disease.
She is now on permanent medication and must wear a 24‑hour opium
patch.
"Sjogren's
disease, by the way, can take years to diagnose. Only long‑term studies will be able to show whether
implants cause this disease.
"My
wife was not informed about the dangers of silicone breast implants. She is serving a life sentence of pain. Normal for my wife has become a loss of physicality,
loss of sleep, and diminished health, which has led to massive medical bills,
bankruptcy, the loss of our farm, and a downward spiral resulted from silicone
gel breast implants.
"Most
women do not know that silicone gel can calcify and mix into breast
tissue. The pain can be extreme, as in
my wife's case. Once this takes place,
the surgeon has to literally scrape the silicone off the chest cavity until
there is nothing left. This was my
wife's experience.
"My
wife no longer has breasts. For women
of childbearing age, this is particularly devastating and can mean the
inability to breast‑feed.
"The
FDA had questions about the safety of implants last year and didn't approve the
application for implants back then. The
real question is, have the manufacturers really answered all of these questions
in the space of one year? Since only
four years worth of data is being presented, I doubt it.
"Please
ask yourself, if the same question exists, then why are we here? I plead with this FDA Advisory Committee to
continue to restrict silicone gel implants while research continues. Do not improve implants which have not been
proven safe for long‑term use.
This is not about aesthetics.
It's about women's health.
"Thank
you."
MS.
STANSELL: I was supposed to have five
minutes.
CHAIRMAN
CHOTI: Please go ahead. Yes.
MS.
STANSELL: Okay. Thank you.
My
name is Anne Stansell, and I have no conflicts of interest. I represent a support group of about 45
women, all with experiences similar to mine.
One, Ann Palmer, a cancer survivor, was in the Mentor study. When her silicone implants ruptured at about
two years, she was dropped from the study.
And her record at Mentor and, thus, presented to you tomorrow shows no
adverse effects. Ann Palmer died of
breast implant complications in 2001.
I
was diagnosed with breast cancer when I was 39. I underwent a mastectomy, radiation therapy, and breast
reconstruction with silicone implants.
Four doctors recommended that I get silicone implants. At the time there was no research on
silicone breast implants in cancer survivors.
But none of the doctors told me that.
Not one of them told me about the risks, the fact that they can rupture
and leak silicone and other chemicals into my body.
Because
of these chemicals in my body, I now get severe headaches when I am exposed to
any common household products with phenolic disinfectant, such as Lysol.
After
six years, I started to get sick with joint pain, muscle pain, skin problems,
dry mouth, and dry eyes. My eyes are so
dry that it has caused a retina to tear.
These are all autoimmune symptoms.
I
was also diagnosed with an autoimmune symptoms called Grave's disease. After fighting cancer, the new illnesses
caused by my implants, I then had to fight with my insurance company to have
the implants removed. You see, the law
states that they must provide implants for mastectomy patients. There is no law that says insurance
companies must replace them in case of rupture or remove them in case of adverse
effects.
When
my implants were removed, half of one of them was gone. This is not surprising given that Inamed's
own data shows that 20 percent of reconstruction patients experience ruptured
implants within just three years.
Studies have shown that silicone can leak into the scar capsule and the
lymph nodes, even when the implants haven't yet ruptured.
After
I had the implants removed, I started to slowly get better. This is also typical. I have read a study by National Cancer
Institute researcher Dr. Noreen Aziz which shows that most women with implants
who have rheumatological symptoms get better when their implants are removed
and not replaced. If their implants
were replaced, most got worse.
I
am not fully recovered, unfortunately.
In addition to continued fatigue, the many surgeries to put in and
remove my implants had left me with such chest tenderness that I cannot have
anything more than a soft t‑shirt on my chest. Now prosthetics even are out of the question.
This
controversy has been going on for 15 years.
The whole new generation is now being seduced into believing these
products are safe when they are not.
No
significant improvements have been made in silicone breast implants in the last
15 years. This is the same product with
new advertising and new hype. Just
because these manufacturers have created a market for their products with
advertising and TV makeover shows does not mean the product is safe.
If
you want to help breast cancer patients, please insist on long‑term safety
data before approving this product. You
owe it to us older women who have suffered for years and years and to the young
women who will suffer for many years if you approve this product.
CHAIRMAN
CHOTI: Thank you.
Yes? Good morning.
DR.
TAYLOR: My name is Dr. Joy Taylor. I was a hospice physician. I have no financial ties to the
manufacturers or their competitors.
I
had breast implants for 18 years before I became ill. A CT scan showed bilateral ruptured implants, and I was diagnosed
with pleurisy and pulmonary fibrosis. I
then began collecting autoimmune disorders.
I
was diagnosed with Hashimoto's thyroiditis, Sjogren's syndrome, autoimmune
diseases that attack the thyroid, the salivary, and the tear glands. I also developed polymyositis, a
coagulopathy, Alzheimer's‑like symptoms, severe fatigue, MS symptoms,
constant tinnitus, and Crohn's disease.
My
colon was perforated in several places and had to be removed. I was in ICU for over six weeks and on life
support and had every complication possible.
The
ICU doctor told my family that in 30 years, he had never seen anyone in my
condition survive. He told my family to
make arrangements for my funeral. I
lived through that crisis, but there were more to come because my body was
producing antibodies that attacked me.
In
addition to all of this, I suffer the debilitating disease porphyria. There are only two ways to get
porphyria: exposure to heavy metals,
like platinum; or heredity. I have no
family history of porphyria. Platinum
exposure causes malfunction of the immune system.
Since
my implants ruptured, I have had ten surgeries. My family has planned my funeral twice. And I am unable to practice medicine. I regret my decision to get implants. And I am alive today because of the skillful, caring doctors and
many prayers. The ICU doctor says I am
a miracle, and he is right.
Please
don't approve silicone implants until they are adequately tested long‑term
and proven safe. Women, after all, have
the right to have accurate information on which they may make an intelligent
decision. Women's health and lives
depend on it.
CHAIRMAN
CHOTI: Excuse me. Were you representing an organization for
that session?
DR.
TAYLOR: Yes, Platinum Awareness.
CHAIRMAN
CHOTI: Thank you very much.
Yes? Next speaker, please. Good morning.
MS.
MARSHALL: Good morning. Good afternoon. Hello. My name is Cindy
Marshall. Here's my story, which is,
sadly, just one of literally hundreds of thousands of similar stories.
Silicone
gel implants have destroyed my precious, priceless health, drastically changing forever the quality of
my life. Women like me are proof of the
truth.
I
still remember the words that board‑certified plastic surgeon spoke to
me, "These implants are safe to last a lifetime." What a wonderful 21st birthday gift,
"You'll forever love how you'll look and feel." If only his words were true.
I
first experienced flu‑like symptoms, hair loss, bone pain, fatigue, which
resulted in countless doctor appointments.
I had three mammograms, beginning in 1997, then in 2000, last in 2003.
The
last mammogram indicated that my silicone gel breast implants were leaking and
ruptured. I had to get explanted
quickly and was in May 2004. By this
time, it was too late. The damage was
already done. My silicone gel breast
implants had leaked and ruptured, leaving me with currently irreversible
damage, silicone poisoning, and silicone‑associated disease.
Here
are just some of the numerous symptoms, conditions, and diseases: swollen lymph nodes; hair loss; chronic bone
muscle; skin tissue and organ pain; connective tissue disease; arthritis;
scalp, face, body rashes; vision problems; blood in stools; blood leakage from
breasts; chronic weakness, fatigue; Raynaud's syndrome; irreversible brain
damage, demyelinating disease; MS‑like.
I
used to have a business in home health care.
Now I am the patient. I
experience scary, unpredictable episodes and attacks during these times in
which I have slurred speech, severe termor, difficulty walking or fall down,
and even episodes of paralysis.
I
must depend on others for my daily needs because of my difficulty
performing. I have difficulty
performing even the simplest of tasks:
using the bathroom, showering, dressing, and feeding myself. One of my doctors now thinks I have lupus.
If
I had been informed of the truth that silicone gel implants were never proven
safe, that they leak, rupture, and bleed toxic substances into the immune
system, contain close to 40 known toxic chemicals, mind you, not meant for
human consumption, never ever would I have consented or allowed them to be put
into my body.
I'm
only 37, a single mom of 3 beautiful girls.
I just want to be here for Brooke, Erica, and Danielle. My children who need their mommy fear for
their mommy, who fears for every young girl and woman everywhere.
FDA,
please support public health safety and not the industry poisoning the
public. Thank you.
CHAIRMAN
CHOTI: Thank you.
Next
speaker?
DR.
MILLER: My name is Dr. Claudia
Miller. I have no financial interests
in this hearing, and I'm here at my own expense. I'm actually a professor at UT Health Science Center in San
Antonio. I'm an
allergist/immunologist. And my research
is focused on people who report chronic disabling symptoms following some
environmental exposure, the symptoms you have heard about today.
I
have served as a consultant to the Department of Veterans Affairs on Gulf War
veterans, the EPA on sick buildings, the National Institute of Dental and
Craniofacial Research on temporomandibular joint implants, where, by the way,
you see similar kinds of complaints.
What
unites ill Gulf War veterans, sick building occupants, and patient with
implants who are having problems is the fact that following a well‑defined
exposure event, a subset, not every one, a subset of them, go on to lose their
prior natural tolerance for a wide variety of substances that are structurally
unrelated.
Thereafter,
common foods, medications, alcoholic beverages, caffeine, chemical inhalants,
like diesel exhaust, and fragrances you have heard about today, exposures that
never bothered people before suddenly trigger symptoms in them. And these can be disabling.
This
two‑step disease process ‑‑ you can go to the next slide ‑‑
has come to be known as toxicant‑induced loss of tolerance, or TILT. It does not appear to matter whether the
exposure that initiated this, which is at the bottom of the right‑hand
slide, was endogenous or exogenous. The
body's response is remarkably similar.
Next
slide. We have reported on 87
individuals with surgical implants, three‑quarters of them with breast
implants. Sixty‑nine percent
reported rupture. Seventy‑eight
percent had one or more implants removed.
Of those who had undergone explanation, less than ten percent reported
their health status as greatly improved.
Next
slide. Using a validated questionnaire,
we found that the symptom severity scores of implant recipients rivaled those
of the environmental exposed groups we were studying. And there were four of those.
Next. Compared to controls, implant recipients
reported much more severe adverse responses to everyday chemical exposures as
well as having problems with various foods, medications, alcoholic beverages,
and caffeine.
We
are a couple of slides behind. Go
ahead. Next slide and then the next
one. Thank you. And then the next one. Toxicant‑induced loss of tolerance is
a new paradigm for environmentally induced disease that differs from classical
toxicity and allergy.
Affected
individuals may be completely unaware of the intolerances resulting from this
because of a phenomenon we call masking.
If a person is reacting to many different things and having symptoms as
a result of those, then the symptoms may overlap in time. And, consequently, they feel sick all of the
time, often reporting chronic fatigue or flu‑like illness that won't go
away.
Recent
Canadian studies show that genetic polymorphisms may determine who is more
vulnerable to developing this illness.
And in September ‑‑ next slide ‑‑ I will be
chairing a meeting on the toxicant‑induced loss of tolerance sponsored by
two NIH institutes where we'll be discussing various aspects, clinical models,
animal models, and so on, in order to understand this problem better in
providing you with a questionnaire that I showed a moment ago to help
physicians and researchers better understand this problem.
And
I will be happy to provide you with any references. Thank you.
CHAIRMAN
CHOTI: Thank you. And I would like to thank all of the
speakers this morning for their time.
We are going to take a lunch break now.
We are going to resume promptly at 1:15. Thank you.
(Whereupon,
at 12:05 p.m., the foregoing matter was recessed for lunch, to reconvene at
1:15 p.m. the same day.)